Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Issue Date: November 22, 2024
Issued by: Center for Devices and Radiological Health,Office of Product Evaluation and Quality,Office of Health Technology VI – Orthopedic Devices
Topic(s): Premarket, 510(k), Orthopedic
Status: Final

Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

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.

Download the Guidance Document