Cleared Traditional

ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP

K930189 · Dow Corning Wright · Orthopedic

Aug 1993

Decision

204d

Days

Class 2

Risk

About This 510(k) Submission

K930189 is an FDA 510(k) clearance for the ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP, 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 6, 1993, 204 days after receiving the submission on January 14, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K930189 FDA.gov
FDA Decision	Cleared SN
Date Received	January 14, 1993
Decision Date	August 06, 1993
Days to Decision	204 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