Cleared Traditional

VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES

K073499 · Zimmer, Inc. · Orthopedic

Aug 2008

Decision

238d

Days

Class 3

Risk

About This 510(k) Submission

K073499 is an FDA 510(k) clearance for the VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES, a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III — Premarket Approval, product code JDL), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 7, 2008, 238 days after receiving the submission on December 13, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K073499 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2007
Decision Date	August 07, 2008
Days to Decision	238 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 888.3320