The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for The Taper-fit Total Hip System.
Device ID | K992234 |
510k Number | K992234 |
Device Name: | THE TAPER-FIT TOTAL HIP SYSTEM |
Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
Contact | Craig Corrance |
Correspondent | Craig Corrance CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
Product Code | JDG |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-02 |
Decision Date | 1999-11-10 |
Summary: | summary |