MBV — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Class II
FDA product code MBV covers "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3560. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MBV
- Device Class
- Class II
- Regulation Number
- 888.3560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K010212 | biomet | OFFSET TIBIAL TRAY | February 14, 2001 |
| K884824 | richards medical co | TRICON-M TOTAL KNEE SYSTEM | November 21, 1989 |
| K873429 | protek | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE | October 28, 1987 |
| K853730 | protek | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP | February 18, 1986 |
| K833200 | richards medical co | TRICON M TOTAL KNEE SYSTEM | November 29, 1983 |
| K831441 | depuy | POROCOAT FREEMAN/SAMUELSON TOTAL KNEE | September 1, 1983 |
| K832302 | advanced biosearch assn | MARK I TOTAL KNEE SYS. ARTHROPLASTY | August 16, 1983 |
| K830726 | advanced biosearch assn | MARK I & II TOTAL KNEE REPLACE. SYS | June 22, 1983 |
| K823837 | richard medical equip | RMC TOTAL KNEE SYSTEM | March 29, 1983 |
| K830408 | depuy | FREEMAN/SAMUELSON TOTAL KNEE | February 24, 1983 |
| K822583 | richard medical equip | TOTAL KNEE SYSTEM | October 4, 1982 |
| K802921 | depuy | ICLH TIBIAL PLATEAU | January 8, 1981 |
| K780904 | depuy | KNEE, TOTAL, FEMORAL & TIBIAL | June 22, 1978 |
| K780284 | depuy | TIBIAL PLATEU | March 15, 1978 |