Orthopedic Surgical Manufacturers Association (OSMA) - Petition for Reclassification

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Orthopedic Surgical Manufacturers Association (OSMA) Attachments A-G - Petition for Reclassification

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Authors: cdrh; cervical spine; lateral mass; pedicle screw spinal systems
 

Attachment F - Bibliography Articles re Lateral Mass and Pedicle Screws

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Authors: cdrh
 

Reference 1 Abumi et al Complications of Pedicle Screw Fixation in Reconstructive Surgery of the Cervical Spine

Authors: cdrh; Kuniyoshi Abumi, MD; Yasuhio Shono, MD; Manabu Lto, MD; Hiroshi Taneichi, MD; Yoshihisa Kotani, MD; Kiyoshi Kaneda, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine 2000 25 962 969
 

Reference 2 Alosh et al Preoperative Radiographic Factors and Surgeon Experience Are Associated With Cortical Breach of C2 Pedicle...

Authors: cdrh; Hassan Alsoh, BS; Scott L. Parker, BS; Matthew J. McGirt, MD; Ziya L. Gokaslan, MD; Timothy F. Witham, MD; Ali Bydon, MD; Jean-Paul Wolinsky, MD; Daniel M. Sciubba, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spinal Disord Tech 2010 231 9 14
 

Reference 3 Arnold et al Posterior Stabilization of Subaxial Cervical Spine Trauma Indications and Techniques

Authors: cdrh; Paul M. Arnold; Mark Bryniarski; Joan K McMahon
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Injury2005 36 Suppl 2 B36 43
 

Reference 4 Aryan et al Stabilization of the Atlantoaxial Complex via C1 Lateral Mass and C2 Pedicle Screw Fixation in a...

Authors: cdrh; Henry E. Aryan, MD; C. Benjamin Newman, MD; Eric W. Nottmeier, MD; Frank L. Acosta Jr., MD; Vincent Y. Wang, MD., Ph.D; Christopher P. Ames, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: JNeurosurgSpine2008 8 3 222 9
 

Reference 5 Bransford et al Posterior Fixation of the Upper Cervical Spine Contemporary Techniques

Authors: cdrh; Richard J. Bransford, MD; Mihael J. Lee, MD; Abilio Reis, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: J Am Acad Orthop Surg 2011 19 2 63 71
 

Reference 6 Cornefjord et al Posterior Fixation of Subaxial Cervical Spine Fractures in Patients With Ankylosing Spondylitis

Authors: cdrh; Michael Cornefjord; M. Alemany; C. Olerud
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: EurSpineJ2005 14 4401 8
 

Reference 7 Deen et al Lateral Mass Screw Rod Fixation of the Cervical Apine A Prospective Clinical Series With 1-Year Follow-up

Authors: cdrh; H. Gordon Deen, MD; Barry D. Birch, MD; Robert E. Wharen, MD; Ronald Reimer, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: SpineJ2003 3 6 489 95
 

Reference 8 Djurasovic et al A Prospective Analysis of Intraoperative Electromyographic Monitoring of Posterior Cervical Screw...

Authors: cdrh; Mladen Djurasovic, MD; John R. Dimar, II, MD; Steven D. Glassman, MD; Harvey L. Edmonds, PhD; Leah Y. Carreon, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: JSpinalDisordTech2005 18 6515 8
 

Reference 9 ElMiligui et al Transpedicular Screw Fixation for Type II Hangmans Fracture A Motion Preserving Procedure

Authors: cdrh; Yasser Elmiligui; Wael Koptan; Ihab Emran
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Eur Spine J 2010 19 8 1299 305
 

Reference 10 Goel et al Atlantoaxial Fixation Using Plate and Screw Method A Report of 160 Treated Patients

Authors: cdrh; Atul Goel, M. CH.; Ketan I. Desani, M.S., M. CH.; Dattatraya P. Muzumdar, M.S., M. CH.
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Neurosurg 2002 51 6 1351-1357
 

Reference 11 Harms et al Posterior C1-C2 Fusion With Polyaxial Screw and Rod Fixation

Authors: cdrh; Jurgen Harms, MD; Robert P. Melcher, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2001 26 22 2467 71
 

Reference 12 Hasegawa et al Indications for Cervical Pedicle Screw Instrumentation in Nontraumatic Lesions 9

Authors: cdrh; Kazuhiro Hasegawa, MD; Toru Hirano, MD; Haruka Shimoda, MD; Takao Homma, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2008 33 21 2284
 

Reference 13 Ishikawa et al Clinical Accuracy of Three-Dimensional Fluoroscopy-Based Computer-Assisted Screw Pedicle Screw...

Authors: cdrh; Yoshimoto Ishikawa, MD; Tokumi Kanenura, MD; Go Yoshida, MD; Zenya Ito, MD; Akio Muramoto, MD; Shuichiro Ohno, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Neurosurg Spine 2010 13 5 606 611
 

Reference 14 Ito et al Clinical Accuracy of 3D Fluoroscopy-Assisted Cervical Pedicle Screw Insertion

Authors: cdrh; Yasuo Ito, MD; Yoshihisa Sugimoto, MD; Masao Tomioka, MD; Yasuhiro Hasegawa, MD; Kie Nakago, MD; Yukihisa Yagata, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: JNeurosurgSpine2008 9 5 450 3
 

Reference 15 Jian et al Direct Posterior Reduction and Fixation for the Treatment of Basilar Invagination with Atlantoaxial...

Authors: cdrh; Feng-Zeng Jian, MD, PhD; Zan Chen, MD, PhD; Karsten H. Wrede, MD; Madjid Samii, MD, PhD; Feng Ling, MD, PhD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: FZ Neurosurg 2010 66 4 678 687
 

Reference 16 Kim et al Early Results From Posterior Cervical Fusion With a Screw-Rod System

Authors: cdrh; Sang Hyun Kim; Dong Ah Shin; Seung Yi; Do Heum Yoon; Keung Nyun Kim; Hyun Chul Shin
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Yonsei MedJ2007 48 3 440 8
 

Reference 17 Kosmopoulos et al Pedicle Screw Placement Accuracy A Meta Analysis

Authors: cdrh; Victor Kosmopoulos, PhD; Constantin Shizas, MD, PD, FRCS
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2007 32 3 E111 120
 

Reference 18 Lee et al Clinical and Radiological Comparison of Treatment of Atlantoaxial Instability by Posterior C1-C2...

Authors: cdrh; Sun-Ho Lee; Eun Sang Kim; Joo-Kyung Sung ; Yeun-Mook Park; Whan Eoh
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: J Clin Neuro 2010 17 886 892
 

Reference 19 Lee et al Clinical Accuracy of Cervicothoracic Pedicle Screw Placement A Comparison of the Open Lamino-Foraminotomy...

Authors: cdrh; Eric M. Massicotte, MD, MSc, FRCSC; Y. Raja Rampersaud, MD FRCSC; Gabriel Y. F. Lee, MBBS (Hons) MS, FRACS
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: SpinalDisordTech2007 20 1 25 32
 

Reference 20 Lei et al Posterior Fixation and Fusion With Atlas Pedicle Screw System for Upper Cervical Diseases

Authors: cdrh; LI Lei; Zhou Feng-hua; Wang Huan; CUI Shao-qian
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Chin J Traumatol2008 11 6323 328
 

Reference 21 Liu et al Posterior Fusion of the Subaxial Cervical Spine Indications and Techniques

Authors: cdrh; James K. Liu, MD; Kaushik Das, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: 2001 Neurosurg Focus 10 4
 

Rrference 22 Liu et al Comparison of the Clinical Accuracy of Cervical C2–C7 Pedicle Screw Insertion Assisted by Fluoroscopy...

Authors: cdrh; LIU Ya-jun; Tian Wei; LIU Bo; LI Qin; HU Lin; LI Zhi-yu; Yuan Qiang; LU Yan-wei; SUN Yu-zhen
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: 2010 Chin Med Z 123 21 2995 8
 

Reference 23 Liu et al Pedicle Screw Fixation for Cervical Spine Instability Clinical Efficacy and Safety Analysis

Authors: cdrh; LIU Yong; HU Jian-hua; YU Ke-yi
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Chinese Medical Journal 2009 122 17 1985 1989
 

Reference 24 Ludwig et al Transpedicle Screw Fixation of the Cervical Spine

Authors: cdrh; Steven C. Ludwig, MD; David L. Kramer, MD; Alexander R. Vaccaro, MD; Todd J. Albert, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: ClinOrthopRelatRes1999 359 77 88
 

Reference 25 Mueller et al Accuracy and Complications of Transpedicular C2 Screw Placement Without the use of Spinal Navigation

Authors: cdrh; Christian-Andreas Mueller; Lukas Roesseler; Martin Podlogar; Attlila Kovacs; Rudolf Andreas Kristof
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: 2010 Eur Spine J 19 5 809 14
 

Reference 26 Neo et al The Clinical Risk of Vertebral Artery Injury From Cervical Pedicle Screws Inserted in Degenerative...

Authors: cdrh; Masahi Neo, MD, PhD; Takeshi Sakamoto, MD, PhD; Shunsuke Fujibayashi, MD, PhD; Takashi Nakamura, MD, PhD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2005 30 24 2800 5
 

Reference 27 Neo et al Vertebral Artery Injury During Cervical Spine Surgery A Survey of More than 5600 Operations

Authors: cdrh; Masashi Neo, MD, PhD; Shunsuke Fujibayashi, MD PhD; Masahiko Miyata, MD; Mitsuru Takemoto, MD, PhD; Takashi Nakamura, MD, PhD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2008 33
 

Reference 28 Oda et al Palliative Spinal Reconstruction Using Cervical Pedicle Screws for Metastatic Lesions of the Spine

Authors: cdrh; Itaru Oda, MD; Kuniyoshi Abumi, MD; Manabu Ito, MD; Yoshihisa Kotani, MD; Takashi Oya, MD; Kyoichi Hasegawa, MD; Akio Minami, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2006 31 131439 44
 

Reference 29 Ogihara et al Long Term Results of Computer Assisted Posterior Occipitocervical Reconstruction

Authors: cdrh; Nobuhide Ogihara; Jun Takahashi; Hiroki Hirabayashi; Hiroyuki Hashidate; Hiroyyuki Kato
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: N World Neurosurg 2010 73 6 722 728
 

Reference 30 Ondra et al Safety and Efficacy of C2 Pedicle Screws Placed With Anatomic and Lateral C Arm Guidance

Authors: cdrh; Stephen L. Ondra, MD; Shaden Marzouk, MD; Aruna Ganju, MD; Thomas Morrison, MD; Tyler Koski, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2006-31 9 E263 7
 

Reference 31 Parker et al Translaminar Versus Pedicle Screw Fixation of C2 Comparison of Surgical Morbidity and Accuracy of 313...

Authors: cdrh; Scott L. Parker, B.S; Matthew J. McGirt, MD; Giannina L. Garces-Ambrossi, B.S.; Vivek A. Mehta, B.S.; Daniel M. Sciubba, MD; Timothy F. Witham, MD; Ziya L. Gokaslan, MD; Jean-Paul Wolinksy, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Neurosurgery2009 64 5 Suppl 2 343 349
 

Reference 32 Richter et al Cervical Pedicle Screws: Conventional Versus Computer-Assisted Placement of Cannulated Screws

Authors: cdrh; Marcus Richter, MD, PhD; Balkan Cakir, MD; Rene Schmidt, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine 2005 30 20 2280 7
 

Reference 33 Sairyo et al Cervical and Upper Thoracic Screwing for Spinal Fusion Strategy for its Safe Insertion to Avoid Major...

Authors: cdrh; Koichi Sairyo; Toshinori Sakai; Koasaku Higashino; Tastsuya Tamura; Shinsuke Katoh; Natsuo Yasui
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: ArchOrthopTraumaSurg2009 129 11 1447 52
 

Reference 34 Sasso C1 Lateral Screws and C2 Pedicle Pars Screws

Authors: cdrh; Rick C. Sasso, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: AAOSInstruct2007 56 311 17
 

Reference 35 Sciubba et al Radiographic and Clinical Evaluation of Free Hand Placement of C 2 Pedicle Screws

Authors: cdrh; Daniel M. Sciubba, MD; Joseph C. Noggle, B.S; Ananth K. Vellimana; Hassan Alosh, B.S; Matthew J. McGrit, MD; Ziya L. Gokaslan, MD; Jean-Paul Wolinsky, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: JNeurosurgSpine2009 11 1 15 22
 

Reference 36 Stulik et al Atlantoaxial Fixation Using the Polyaxial Screw Rod System

Authors: cdrh; Jan Stulik ; Tomas Vyskocil; Petr Sebesta; Jan Kryl
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: EurSpineJ2007 16 4 479 84
 

Reference 37 Tan et al C1 Lateral Mass C2 Pedicle Screws and Crosslink Compression Fixation for Unstable Atlas Fracture

Authors: cdrh; Jun Tan, MD; LiJun Li, MD; Guixin Sun, MD; Lie Qian, MD; Mingjie Yang, MD; Cheng Zeng, MD; Honglin Teng, MD; Lianshun Jia, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine2009 34 23 2505 9
 

Reference 38 Wang et al Radiographic Evaluation of the Technique for C1 Lateral Mass and C2 Pedicle Screw Fixation in Three...

Authors: cdrh; Shenglin Wang, MD; Chao Wang, MD; Kirkham B. Wood, MD; Ming Yan, MD; Haitao Zhou, MD
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine 2011 36 1 3 8
 

Reference 39 Yoshimoto et al Clinical Accuracy of Cervical Pedicle Screw Insertion Using Lateral Fluoroscopy A Radiographic...

Authors: cdrh; Hisashi Yoshimoto; Shigenobu Sato; Takahiko Hyakumaci ; Yasushi Yanagibashi; Taiki Kanno; Takeshi Masuda
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: EurSpineJ2009 18 9 1326 34
 

Reference 40 Yukawa et al Placement and Complications of Cervical Pedicle Screws in 144 Cervical Trauma Patients Using Pedicle...

Authors: Yasutsugu Yukawa; Fumihiko Kato; Keigo Ito; Yumiko Horie; Tetsurou Hida; Hiroaki Nakashima; Masaaki Machino; cdrh
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: EurSpineJ2009 18 9 1293 9
 

Reference 41 Zhou Management of Fracture Disclocation of the Lower Cervical Spine With the Pedicle Screw System

Authors: cdrh; Feng Zhou; Jun Zou; Minfeng Gan; Ruofu Zhu; Huilian Yang
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: F Ann R Coll Surg Eng 2010 92 5 406 410
 

Reference 42 Bapat et al Role of Transarticular Screw Fixation in Tuberculous Atlantoaxial Instability

Authors: cdrh; Mihir R. Bapat; Vinod J. Lahiri; N.S. Harshavardhan; Umesh S. Metkar; Kshitij C. Chaudhary
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: 2007 Eur Spine J p187 197
 

Reference 43 Epstein The Value of Anterior Cervical Plating in Preventing Vertebral Fracture and Graft Extrusion After Multilevel...

Authors: Nancy E. Epstein
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: 2000 J Spinal Disord p9 15
 

Reference 44 Fagerstrom et al Cotrel Dubousset Instrumentation in Occipito Cervico Thoracic Fusion

Authors: cdrh; Teddy Fagerstrom; Rune Hedlund
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: 2002 EurSpineJ p364 74
 

Reference 45 Reilly et al Atlantoaxial Stabilization Clinical Comparison of Posterior Cervical Wiring Technique With...

Authors: cdrh; Thomas M. Reilly; Rick C. Sasso; Peter V. Hall
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: 2003 Spine p248 53
 

Reference 46 Zimmerman et al Clinical Article Palliative Occipito Cervical Stabilization in Patients with Malignant Tumors of the...

Authors: R. Wolff; M. Zimmerman; A. Raabe; D. Stolke; V. Seifert
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
Publication Reference: Spine ActaNeuro 2002 144 8 783 90
 

 
 
ID: FDA-2011-P-0851-0001

Document Information

Date Posted: Dec 6, 2011
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Submitter Information

Country: United States
State or Province: TN
Category: Association - D0003

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Comments Received*
North American Spine Society Response: 513(e) Petition for Reclassification: Posterior Cervical Pedicle and Lateral Mass Screws

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