The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Repicci Ii Onlay Unicompartmental Tibial Component.
| Device ID | K053299 |
| 510k Number | K053299 |
| Device Name: | REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2006-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304448315 | K053299 | 000 |
| 00880304447042 | K053299 | 000 |
| 00880304447035 | K053299 | 000 |
| 00880304447028 | K053299 | 000 |
| 00880304447011 | K053299 | 000 |
| 00880304447004 | K053299 | 000 |
| 00880304446991 | K053299 | 000 |
| 00880304446984 | K053299 | 000 |
| 00880304446977 | K053299 | 000 |
| 00880304447059 | K053299 | 000 |
| 00880304447066 | K053299 | 000 |
| 00880304447639 | K053299 | 000 |
| 00880304447134 | K053299 | 000 |
| 00880304447127 | K053299 | 000 |
| 00880304447110 | K053299 | 000 |
| 00880304447103 | K053299 | 000 |
| 00880304447097 | K053299 | 000 |
| 00880304447080 | K053299 | 000 |
| 00880304447073 | K053299 | 000 |
| 00880304446960 | K053299 | 000 |