[US, FDA] Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions

This guidance document provides the FDA’s recommendations on information to support premarket submissions for orthopedic non-spinal bone plates, screws, and washers. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of orthopedic non-spinal bone plate, screw, and washer submissions.

 

 

Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions | FDA

Orthopedic Non-Spinal Bone Plates, Screws, and Washers 510(k) Guidance

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