Cleared Traditional

CORIN METAFIX HIP STEM

K130634 · Corin USA · Orthopedic

May 2013

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K130634 is an FDA 510(k) clearance for the CORIN METAFIX HIP STEM, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on May 24, 2013, 74 days after receiving the submission on March 11, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K130634 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2013
Decision Date	May 24, 2013
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353