The following data is part of a premarket notification filed by Biologically Oriented Prostheses with the FDA for Townley All Poly Acetabular Cup.
| Device ID | K952731 |
| 510k Number | K952731 |
| Device Name: | TOWNLEY ALL POLY ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | Cheryl L Warsinske |
| Correspondent | Cheryl L Warsinske BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH 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 | 1995-06-15 |
| Decision Date | 1995-12-28 |