510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K973231Substantially Equivalent

The Corifix Dynamic Hip Screw System

Corin USA, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973231 is the FDA 510(k) clearance record for THE CORIFIX DYNAMIC HIP SCREW SYSTEM, a class II device, cleared for Corin USA on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list 78 510(k) clearances for Corin USA, from to . As of , FDA records show no recalls naming K973231.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Corin USA 10500 University Center Dr., Tampa FL
510(k) summary
Summary
Third party review
No

Clearances, product code KTT

Trailing 12 months
7 clearances under product code KTT in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KTT, trailing twelve months
MonthClearances
December 20252
January 20261
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261
November 20260