Cleared Special

CONSERVE FEMORAL RESURFACING COMPONENT

K062960 · Wrightmedicaltechnologyinc · Orthopedic
Dec 2006
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K062960 is an FDA 510(k) clearance for the CONSERVE FEMORAL RESURFACING COMPONENT, a Prosthesis, Hip, Femoral, Resurfacing (Class II — Special Controls, product code KXA), submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on December 1, 2006, 63 days after receiving the submission on September 29, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3400.

Submission Details

510(k) Number K062960 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2006
Decision Date December 01, 2006
Days to Decision 63 days
Submission Type Special
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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