Cleared Traditional

PINNACLE CONSTRAINED ACETABULAR LINERS

K043058 · Depuy, Inc. · Orthopedic

Mar 2005

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K043058 is an FDA 510(k) clearance for the PINNACLE CONSTRAINED ACETABULAR LINERS, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II — Special Controls, product code KWZ), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 14, 2005, 129 days after receiving the submission on November 5, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number	K043058 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2004
Decision Date	March 14, 2005
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3310