The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Proximal Femoral Articular Replacement.
| Device ID | K894604 |
| 510k Number | K894604 |
| Device Name: | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Contact | Serafin, Jr |
| Correspondent | Serafin, Jr BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-11-17 |