Cleared Traditional

AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM

K962002 · Exactech, Inc. · Orthopedic
Aug 1996
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K962002 is an FDA 510(k) clearance for the AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 8, 1996, 78 days after receiving the submission on May 22, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K962002 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1996
Decision Date August 08, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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