The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mck Maximum Congruent Knee) Knee System.
| Device ID | K915132 |
| 510k Number | K915132 |
| Device Name: | MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia S.beres |
| Correspondent | Patricia S.beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304231603 | K915132 | 000 |
| 00880304010093 | K915132 | 000 |
| 00880304007611 | K915132 | 000 |
| 00880304006874 | K915132 | 000 |
| 00880304005815 | K915132 | 000 |
| 00880304001244 | K915132 | 000 |
| 00880304001237 | K915132 | 000 |
| 00880304001220 | K915132 | 000 |
| 00880304000780 | K915132 | 000 |
| 00880304010215 | K915132 | 000 |
| 00880304018273 | K915132 | 000 |
| 00880304231566 | K915132 | 000 |
| 00880304018389 | K915132 | 000 |
| 00880304018372 | K915132 | 000 |
| 00880304018358 | K915132 | 000 |
| 00880304018334 | K915132 | 000 |
| 00880304018327 | K915132 | 000 |
| 00880304018310 | K915132 | 000 |
| 00880304018280 | K915132 | 000 |
| 00880304000476 | K915132 | 000 |