The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for C Fit Cup.
| Device ID | K903938 |
| 510k Number | K903938 |
| Device Name: | C FIT CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ORTHOPEDIC SYSTEMS, INC. C/O SURGICAL IMPLANTS, INC. 6535 EAST 82ND STREET, STE 202 Indianapolis, IN 46250 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart ORTHOPEDIC SYSTEMS, INC. C/O SURGICAL IMPLANTS, INC. 6535 EAST 82ND STREET, STE 202 Indianapolis, IN 46250 |
| 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 | 1990-08-27 |
| Decision Date | 1991-01-04 |