Cleared Traditional

UNI-POLAR HEAD

K896580 · Richards Medical Co., Inc. · Orthopedic
Feb 1990
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K896580 is an FDA 510(k) clearance for the UNI-POLAR HEAD, a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II — Special Controls, product code LZY), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on February 15, 1990, 90 days after receiving the submission on November 17, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K896580 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1989
Decision Date February 15, 1990
Days to Decision 90 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