The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Opti-fix Total Hip System.
| Device ID | K860635 |
| 510k Number | K860635 |
| Device Name: | OPTI-FIX TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-20 |
| Decision Date | 1986-03-14 |