The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Rmhs Monolithic Femoral Component.
| Device ID | K931642 |
| 510k Number | K931642 |
| Device Name: | RMHS MONOLITHIC FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-02 |
| Decision Date | 1994-04-29 |