Cleared Traditional

MODULAR CATHCART FRACTURE SYSTEM

K903084 · Depuy, Inc. · Orthopedic
Oct 1990
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K903084 is an FDA 510(k) clearance for the MODULAR CATHCART FRACTURE SYSTEM, a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II — Special Controls, product code LZY), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 3, 1990, 83 days after receiving the submission on July 12, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K903084 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1990
Decision Date October 03, 1990
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360