The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Lima Cement Restrictor.
Device ID | K911338 |
510k Number | K911338 |
Device Name: | LIMA CEMENT RESTRICTOR |
Classification | Prosthesis, Hip, Cement Restrictor |
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 | JDK |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-26 |
Decision Date | 1991-06-28 |