The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History.

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第一作者： Jonathan H,Sussman

第一单位： Department of Neurosurgery, Perelman School of Medicine, 3400 Civic Center Blvd, Floor 15, 19104, Philadelphia, PA, USA. jonathan.sussman@pennmedicine.upenn.edu.

作者： Jonathan H,Sussman ^[1] ; Ahmed,Albayar ^[2] ; Anissa,Saylany ^[3] ; Bhargavi R,Budihal ^[3] ; Dominic,Romeo ^[3] ; Jason,Xu ^[4] ; Joshua,Rosenow ^[3] ; Robert F,Heary ^[5] ; William C,Welch ^[6]

作者单位： Department of Neurosurgery, Perelman School of Medicine, 3400 Civic Center Blvd, Floor 15, 19104, Philadelphia, PA, USA. jonathan.sussman@pennmedicine.upenn.edu. ^[1] Medical Scientist Training Program, University of Pennsylvania, Philadelphia, PA, USA. jonathan.sussman@pennmedicine.upenn.edu. ^[2] Department of Neurosurgery, Perelman School of Medicine, 3400 Civic Center Blvd, Floor 15, 19104, Philadelphia, PA, USA. ^[3] Division of Plastic, Reconstructive and Oral Surgery, Children's Hospital of Philadelphia, Pennsylvania, USA. ^[4] Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. ^[5] Division of Neurological Surgery, Mountainside Medical Center, Hackensack Meridian School of Medicine, Montclair, New Jersey, USA. ^[6]

关键词 Cervical screws Device classification FDA regulation Food, drug, and cosmetic act Lateral mass screws Pedicle screw systems

主题词美国食品和药物管理局(United States Food and Drug Administration);美国(United States);人类(Humans);颈椎(Cervical Vertebrae);设备批准(Device Approval);历史, 21世纪(History, 21st Century);历史, 20世纪(History, 20th Century)

DOI 10.1007/s43441-024-00654-1

PMID 38622455

发布时间 2024-06-15

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Therapeutic innovation & regulatory science

2024年58卷4期

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The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History.

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The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History.

Therapeutic innovation & regulatory science

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Therapeutic innovation & regulatory science

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