The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Ziralloy Modular Femoral Heads.
| Device ID | K912641 |
| 510k Number | K912641 |
| Device Name: | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-14 |
| Decision Date | 1991-11-27 |