510(k) K010212
K010212 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "OFFSET TIBIAL TRAY". The FDA issued a decision of Substantially Equivalent on February 14, 2001. The device falls under product code MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2001
- Date Received
- January 23, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type