Cleared Traditional

K920593 - CERAMIC FEMORAL HEAD
(FDA 510(k) Clearance)

K920593 · Dow Corning Wright · Orthopedic

Aug 1992

Decision

202d

Days

Class 2

Risk

K920593 is an FDA 510(k) clearance for the CERAMIC FEMORAL HEAD, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on August 31, 1992, 202 days after receiving the submission on February 11, 1992. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K920593 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 1992
Decision Date	August 31, 1992
Days to Decision	202 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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