The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Press-fit Head Resurfacing Device.
| Device ID | K023188 |
| 510k Number | K023188 |
| Device Name: | PRESS-FIT HEAD RESURFACING 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-24 |
| Decision Date | 2002-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304473584 | K023188 | 000 |
| 00880304473430 | K023188 | 000 |
| 00880304473447 | K023188 | 000 |
| 00880304473454 | K023188 | 000 |
| 00880304473461 | K023188 | 000 |
| 00880304473478 | K023188 | 000 |
| 00880304473485 | K023188 | 000 |
| 00880304473492 | K023188 | 000 |
| 00880304473508 | K023188 | 000 |
| 00880304473515 | K023188 | 000 |
| 00880304473522 | K023188 | 000 |
| 00880304462458 | K023188 | 000 |