The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Distal Centralizers.
| Device ID | K193546 |
| 510k Number | K193546 |
| Device Name: | Distal Centralizers |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Contact | Jessica Andreshak |
| Correspondent | Rhonda Myer Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868273247 | K193546 | 000 |
| 00887868542480 | K193546 | 000 |
| 00887868542473 | K193546 | 000 |
| 00887868542466 | K193546 | 000 |
| 00887868542459 | K193546 | 000 |
| 00887868542435 | K193546 | 000 |
| 00887868542428 | K193546 | 000 |
| 00887868542411 | K193546 | 000 |
| 00887868542404 | K193546 | 000 |
| 00887868542398 | K193546 | 000 |
| 00887868542497 | K193546 | 000 |
| 00880304253117 | K193546 | 000 |
| 00887868273223 | K193546 | 000 |
| 00880304253223 | K193546 | 000 |
| 00880304253216 | K193546 | 000 |
| 00880304253131 | K193546 | 000 |
| 00880304253100 | K193546 | 000 |
| 00880304253094 | K193546 | 000 |
| 00880304009189 | K193546 | 000 |
| 00880304001169 | K193546 | 000 |
| 00880304253124 | K193546 | 000 |
| 00887868542381 | K193546 | 000 |