The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Drg Custom Hip Replacement System.
| Device ID | K920145 |
| 510k Number | K920145 |
| Device Name: | BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Contact | Louis A Serafin |
| Correspondent | Louis A Serafin 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 | 1992-01-13 |
| Decision Date | 1992-10-15 |