The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom Opc (one-piece Cemented) Ii Femoral Hip Prosthesis.
| Device ID | K951084 |
| 510k Number | K951084 |
| Device Name: | S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Kevin J Crossen |
| Correspondent | Kevin J Crossen JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-05-31 |