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

29 March 2023 – the FDA published draft guidance on the premarket submissions for orthopedic non-spinal bone plates, screws, and washers. Submit comments by 29 May 2023.

This draft guidance document provides recommendations for premarket notification (510(k)) submissions for non-resorbable bone plate, screw, and washer devices. These devices are indicated for orthopedic bone fixation and exclude indications for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /