The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Austin-moore Modular Hip Prosthesis.
| Device ID | K845025 |
| 510k Number | K845025 |
| Device Name: | AUSTIN-MOORE MODULAR HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-27 |
| Decision Date | 1985-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304228290 | K845025 | 000 |
| 00880304000735 | K845025 | 000 |
| 00880304068100 | K845025 | 000 |
| 00880304227972 | K845025 | 000 |
| 00880304228054 | K845025 | 000 |
| 00880304228184 | K845025 | 000 |
| 00880304228214 | K845025 | 000 |
| 00880304228221 | K845025 | 000 |
| 00880304228245 | K845025 | 000 |
| 00880304228269 | K845025 | 000 |
| 00880304000148 | K845025 | 000 |