The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Feldmuehle Ceramic Head (12/14 X 28mm).
Device ID | K910547 |
510k Number | K910547 |
Device Name: | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
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 | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-07 |
Decision Date | 1991-04-12 |