Clearance Summary
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm received FDA 510(k) clearance under submission number K201336, sponsored by Synthes (USA) Products, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-09-03.
- Submission: K201336
- Applicant / Sponsor: Synthes (USA) Products, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2020-09-03
Classification & Regulation
This clearance is catalogued under FDA product code JDS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.