The following data is part of a premarket notification filed by Biologically Oriented Prostheses with the FDA for Various Uhmwp Hip & Knee Joint Prosthesis Modified.
| Device ID | K951356 |
| 510k Number | K951356 |
| Device Name: | VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | Marc F Malooley |
| Correspondent | Marc F Malooley BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | LPH |
| Subsequent Product Code | HSX |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JWH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-24 |
| Decision Date | 1995-06-19 |