The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Modified Freeman Revision Acetabular Cup.
Device ID | K902111 |
510k Number | K902111 |
Device Name: | MODIFIED FREEMAN REVISION ACETABULAR CUP |
Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
Contact | Douglas W Stuart |
Correspondent | Douglas W Stuart TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
Product Code | KWA |
CFR Regulation Number | 888.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-09 |
Decision Date | 1990-08-22 |