Cleared Traditional

ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT

K932911 · Dow Corning Wright · Orthopedic

Jun 1994

Decision

379d

Days

Class 2

Risk

About This 510(k) Submission

K932911 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM L.S. 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 30, 1994, 379 days after receiving the submission on June 16, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K932911 FDA.gov
FDA Decision	Cleared SN
Date Received	June 16, 1993
Decision Date	June 30, 1994
Days to Decision	379 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