Cleared Traditional

ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT

K932210 · Dow Corning Wright · Orthopedic

Sep 1994

Decision

488d

Days

Class 2

Risk

About This 510(k) Submission

K932210 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM 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 September 7, 1994, 488 days after receiving the submission on May 7, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K932210 FDA.gov
FDA Decision	Cleared SN
Date Received	May 07, 1993
Decision Date	September 07, 1994
Days to Decision	488 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

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