The following data is part of a premarket notification filed by Biologically Oriented Prostheses with the FDA for Biopro Hemi-endo Modular Ceramic Head.
| Device ID | K954768 |
| 510k Number | K954768 |
| Device Name: | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | Valerie Gardner |
| Correspondent | Valerie Gardner BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH 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 | 1995-10-17 |
| Decision Date | 1996-01-18 |