Cleared Traditional

CONSERVE PRESSFIT FEMORAL COMPONENT

K082673 · Wrightmedicaltechnologyinc · Orthopedic
Dec 2008
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K082673 is an FDA 510(k) clearance for the CONSERVE PRESSFIT FEMORAL 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 12, 2008, 88 days after receiving the submission on September 15, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3400.

Submission Details

510(k) Number K082673 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2008
Decision Date December 12, 2008
Days to Decision 88 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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