The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Venus Hip.
Device ID | K913708 |
510k Number | K913708 |
Device Name: | VENUS HIP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
Contact | D. W Stuart |
Correspondent | D. W Stuart TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
Product Code | LWJ |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-16 |
Decision Date | 1992-01-27 |