The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for The Corifix Dynamic Hip Screw System.
Device ID | K973231 |
510k Number | K973231 |
Device Name: | THE CORIFIX DYNAMIC HIP SCREW SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
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 | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-27 |
Decision Date | 1997-11-20 |
Summary: | summary |