The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Cemented Femoral Head Resurfing Device.
| Device ID | K021799 |
| 510k Number | K021799 |
| Device Name: | CEMENTED FEMORAL HEAD RESURFING DEVICE |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-31 |
| Decision Date | 2002-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304684416 | K021799 | 000 |
| 00880304684232 | K021799 | 000 |
| 00880304684225 | K021799 | 000 |
| 00880304684218 | K021799 | 000 |
| 00880304684201 | K021799 | 000 |
| 00880304462465 | K021799 | 000 |
| 00880304247871 | K021799 | 000 |
| 00880304247864 | K021799 | 000 |
| 00880304247857 | K021799 | 000 |
| 00880304247840 | K021799 | 000 |
| 00880304247833 | K021799 | 000 |
| 00880304247826 | K021799 | 000 |
| 00880304247802 | K021799 | 000 |
| 00880304247796 | K021799 | 000 |
| 00880304247789 | K021799 | 000 |
| 00880304684249 | K021799 | 000 |
| 00880304684256 | K021799 | 000 |
| 00880304684263 | K021799 | 000 |
| 00880304684409 | K021799 | 000 |
| 00880304684393 | K021799 | 000 |
| 00880304684386 | K021799 | 000 |
| 00880304684379 | K021799 | 000 |
| 00880304684362 | K021799 | 000 |
| 00880304684355 | K021799 | 000 |
| 00880304684348 | K021799 | 000 |
| 00880304684331 | K021799 | 000 |
| 00880304684324 | K021799 | 000 |
| 00880304684317 | K021799 | 000 |
| 00880304684300 | K021799 | 000 |
| 00880304684294 | K021799 | 000 |
| 00880304684287 | K021799 | 000 |
| 00880304684270 | K021799 | 000 |
| 00880304247772 | K021799 | 000 |