Cleared Traditional

ZIRCONIA CERAMIC HEAD ADD'L SIZES

K896204 · Richards Medical Co., Inc. · Orthopedic

Nov 1989

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K896204 is an FDA 510(k) clearance for the ZIRCONIA CERAMIC HEAD ADD'L SIZES, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on November 20, 1989, 25 days after receiving the submission on October 26, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K896204 FDA.gov
FDA Decision	Cleared SN
Date Received	October 26, 1989
Decision Date	November 20, 1989
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353