The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Trinity Acetabular System.
Device ID | K093472 |
510k Number | K093472 |
Device Name: | TRINITY ACETABULAR SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
Contact | Ashlea Bowen |
Correspondent | Ashlea Bowen CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
Product Code | MEH |
Subsequent Product Code | LWJ |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-06 |
Decision Date | 2010-11-23 |
Summary: | summary |