Clearance Summary
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 received FDA 510(k) clearance under submission number K063414, sponsored by Encore Medical L.P.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-12-12.
- Submission: K063414
- Applicant / Sponsor: Encore Medical L.P.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3330
- Decision date: 2006-12-12
Classification & Regulation
This clearance is catalogued under FDA product code KWA and 21 CFR 888.3330, within the Orthopedic review panel as a Class III device.