Cleared Traditional

LACEY ALL POLYETHYLENE TIBIAL COMPONENT

K934354 · Dow Corning Wright · Orthopedic

Jun 1994

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K934354 is an FDA 510(k) clearance for the LACEY ALL POLYETHYLENE TIBIAL COMPONENT, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on June 3, 1994, 269 days after receiving the submission on September 7, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K934354 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 1993
Decision Date	June 03, 1994
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560