The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Maxim Rpg Ps Femoral Component.
| Device ID | K012348 |
| 510k Number | K012348 |
| Device Name: | MAXIM RPG PS FEMORAL COMPONENT |
| 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 | Michelle Mckinley |
| Correspondent | Michelle Mckinley 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-24 |
| Decision Date | 2001-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304131880 | K012348 | 000 |
| 00880304131873 | K012348 | 000 |
| 00880304131866 | K012348 | 000 |
| 00880304131828 | K012348 | 000 |
| 00880304131811 | K012348 | 000 |
| 00880304131804 | K012348 | 000 |