The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Metal-on-metal Hip Systems- Expanded Contraindications.
| Device ID | K082446 |
| 510k Number | K082446 |
| Device Name: | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-25 |
| Decision Date | 2008-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304185746 | K082446 | 000 |
| 00880304002296 | K082446 | 000 |
| 00880304004061 | K082446 | 000 |
| 00880304005785 | K082446 | 000 |
| 00880304008694 | K082446 | 000 |
| 00880304008700 | K082446 | 000 |
| 00880304185630 | K082446 | 000 |
| 00880304185708 | K082446 | 000 |
| 00880304185715 | K082446 | 000 |
| 00880304001961 | K082446 | 000 |