Clearance Summary
Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins received FDA 510(k) clearance under submission number K162124, sponsored by DePuy Synthes. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-03-29.
- Submission: K162124
- Applicant / Sponsor: DePuy Synthes
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-03-29
Classification & Regulation
This clearance is catalogued under FDA product code JDP and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.