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# Non-Spinal Orthopedic Plate 510(k) Guidance
- URL: https://www.fdaweb.com/non-spinal-orthopedic-plate-510-k-guidance/
- Published: 2023-03-28T12:00:00.000Z
- Updated: 2026-09-14T18:22:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154077

FDA has published a draft guidance, *Orthopedic Non-Spinal Bone Plates, Screws, and Washers—Premarket Notification (510(k)) Submissions*, with recommendations for such submissions for non-resorbable bone plate, screw, and washer devices. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-non-spinal-bone-plates-screws-and-washers-premarket-notification-510k-submissions?ref=fdaweb.com) says the devices are installed for orthopedic bone fixation and exclude indications for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation.