Cleared Traditional

K931194 - CO-CR ANSWER FEMORAL COMPONENT (FDA 510(k) Clearance)

K931194 · Biomet, Inc. · Orthopedic device
May 1994
Decision
422d
Days
Class 2
Risk

K931194 is an FDA 510(k) clearance for the CO-CR ANSWER 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 May 5, 1994, 422 days after receiving the submission on March 9, 1993.

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

Submission Details

510(k) Number K931194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date May 05, 1994
Days to Decision 422 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

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