Clearance Summary
DePuy Synthes Trauma Screws received FDA 510(k) clearance under submission number K192745, sponsored by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-11-26.
- Submission: K192745
- Applicant / Sponsor: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2019-11-26
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.