The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Opti-fix Acetabular Component.
| Device ID | K864857 |
| 510k Number | K864857 |
| Device Name: | OPTI-FIX ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556045695 | K864857 | 000 |
| 00885556019917 | K864857 | 000 |
| 00885556019955 | K864857 | 000 |
| 00885556020036 | K864857 | 000 |
| 00885556020043 | K864857 | 000 |
| 00885556020265 | K864857 | 000 |
| 00885556020388 | K864857 | 000 |
| 00885556020913 | K864857 | 000 |
| 00885556021019 | K864857 | 000 |
| 00885556021026 | K864857 | 000 |
| 00885556021231 | K864857 | 000 |
| 00885556021439 | K864857 | 000 |
| 00885556021590 | K864857 | 000 |
| 00885556021637 | K864857 | 000 |
| 00885556021910 | K864857 | 000 |
| 03596010514059 | K864857 | 000 |