Cleared Traditional

LACEY REVISION FEMORAL COMPONENT

K925900 · Dow Corning Wright · Orthopedic

Aug 1993

Decision

277d

Days

Class 2

Risk

About This 510(k) Submission

K925900 is an FDA 510(k) clearance for the LACEY REVISION FEMORAL 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 August 24, 1993, 277 days after receiving the submission on November 20, 1992. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K925900 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 1992
Decision Date	August 24, 1993
Days to Decision	277 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