Cleared Traditional

CORIN TRIFIT TS HIP

K121563 · Corin USA · Orthopedic

Oct 2012

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K121563 is an FDA 510(k) clearance for the CORIN TRIFIT TS HIP, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on October 5, 2012, 129 days after receiving the submission on May 29, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K121563 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2012
Decision Date	October 05, 2012
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353