The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Metal Backed Cemented Acetabular Cup.
| Device ID | K910352 |
| 510k Number | K910352 |
| Device Name: | BIOPRO METAL BACKED CEMENTED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-06-13 |