Clearance Summary
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER received FDA 510(k) clearance under submission number K052639, sponsored by Biomet Manufacturing, 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 2006-05-03.
- Submission: K052639
- Applicant / Sponsor: Biomet Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3350
- Decision date: 2006-05-03
Classification & Regulation
This clearance is catalogued under FDA product code JDI and 21 CFR 888.3350, within the Orthopedic review panel as a Class II device.