Cleared Traditional

K942027 - IMPACT CO-CR 1-PIECE FEMORAL COMPONENT (FDA 510(k) Clearance)

K942027 · Biomet, Inc. · Orthopedic device
Sep 1994
Decision
146d
Days
Class 2
Risk

K942027 is an FDA 510(k) clearance for the IMPACT CO-CR 1-PIECE FEMORAL COMPONENT. This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 19, 1994, 146 days after receiving the submission on April 26, 1994.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K942027 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 26, 1994
Decision Date September 19, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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