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 |