Cleared Traditional

CORMET CEMENTLESS RESURFACING FEMORAL HEAD

K092198 · Corin USA · Orthopedic
Apr 2010
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K092198 is an FDA 510(k) clearance for the CORMET CEMENTLESS RESURFACING FEMORAL HEAD, a Prosthesis, Hip, Femoral, Resurfacing (Class II — Special Controls, product code KXA), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on April 15, 2010, 268 days after receiving the submission on July 21, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3400.

Submission Details

510(k) Number K092198 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2009
Decision Date April 15, 2010
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KXA — Prosthesis, Hip, Femoral, Resurfacing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3400

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