Cleared Traditional

K930188 - ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT
(FDA 510(k) Clearance)

K930188 · Dow Corning Wright · Orthopedic

Aug 1993

Decision

201d

Days

Class 2

Risk

K930188 is an FDA 510(k) clearance for the ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT. This device is classified as 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 3, 1993, 201 days after receiving the submission on January 14, 1993.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K930188 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 1993
Decision Date	August 03, 1993
Days to Decision	201 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