The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Maxim Knee System.
| Device ID | K993159 |
| 510k Number | K993159 |
| Device Name: | MAXIM KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-21 |
| Decision Date | 1999-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304233744 | K993159 | 000 |
| 00880304000773 | K993159 | 000 |
| 00880304001206 | K993159 | 000 |
| 00880304001213 | K993159 | 000 |
| 00880304003873 | K993159 | 000 |
| 00880304003880 | K993159 | 000 |
| 00880304009097 | K993159 | 000 |
| 00880304010079 | K993159 | 000 |
| 00880304010086 | K993159 | 000 |
| 00880304233669 | K993159 | 000 |
| 00880304233706 | K993159 | 000 |
| 00880304000483 | K993159 | 000 |