The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Geri Total Hip System.
| Device ID | K905186 |
| 510k Number | K905186 |
| Device Name: | GERI TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert Games |
| Correspondent | Robert Games SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-19 |
| Decision Date | 1991-02-15 |