Cleared Traditional

REVIVAL(TM) Modular Revision Hip Stem

K152903 · Corin USA · Orthopedic

Apr 2016

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K152903 is an FDA 510(k) clearance for the REVIVAL(TM) Modular Revision 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 April 29, 2016, 211 days after receiving the submission on October 1, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K152903 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2015
Decision Date	April 29, 2016
Days to Decision	211 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