Clearance Summary
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA received FDA 510(k) clearance under submission number K113756, 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 2012-03-14.
- Submission: K113756
- Applicant / Sponsor: Encore Medical L.P.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2012-03-14
Classification & Regulation
This clearance is catalogued under FDA product code OIY and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.