The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Corin Trinity Acetabular System Ecima Liners.
Device ID | K111481 |
510k Number | K111481 |
Device Name: | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS |
Classification | Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented |
Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
Contact | Lucinda Gerber |
Correspondent | Lucinda Gerber CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
Product Code | OQI |
Subsequent Product Code | LZO |
Subsequent Product Code | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-27 |
Decision Date | 2012-02-06 |
Summary: | summary |