Cleared Traditional

ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)

K885069 · Richards Medical Co., Inc. · Orthopedic

Sep 1989

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K885069 is an FDA 510(k) clearance for the ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED), 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 September 1, 1989, 267 days after receiving the submission on December 8, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K885069 FDA.gov
FDA Decision	Cleared SN
Date Received	December 08, 1988
Decision Date	September 01, 1989
Days to Decision	267 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