The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Taperfit Hip Stem.
Device ID | K142761 |
510k Number | K142761 |
Device Name: | Corin TaperFit Hip Stem |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
Contact | Diana L Nader-martone |
Correspondent | Diana L Nader-martone CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-25 |
Decision Date | 2015-04-03 |
Summary: | summary |