The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Repicci Ii Unicondylar Knee All Poly Tibial Components.
| Device ID | K980665 |
| 510k Number | K980665 |
| Device Name: | REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 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 | 1998-02-20 |
| Decision Date | 1998-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304184923 | K980665 | 000 |
| 00880304008144 | K980665 | 000 |
| 00880304008137 | K980665 | 000 |
| 00880304008083 | K980665 | 000 |
| 00880304002401 | K980665 | 000 |