The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Titanium Repicci Ii Unicondylar Femoral Knee Components Cocr Repicci Ii Unicondylar Knee.
| Device ID | K063515 |
| 510k Number | K063515 |
| Device Name: | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander 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 | 2006-11-21 |
| Decision Date | 2007-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304653153 | K063515 | 000 |
| 00880304653054 | K063515 | 000 |
| 00880304653061 | K063515 | 000 |
| 00880304653078 | K063515 | 000 |
| 00880304653085 | K063515 | 000 |
| 00880304653092 | K063515 | 000 |
| 00880304653108 | K063515 | 000 |
| 00880304653115 | K063515 | 000 |
| 00880304653122 | K063515 | 000 |
| 00880304653139 | K063515 | 000 |
| 00880304653146 | K063515 | 000 |
| 00880304653047 | K063515 | 000 |