Cleared Special

K041586 - PROFEMUR S HIP STEM
(FDA 510(k) Clearance)

K041586 · Wrightmedicaltechnologyinc · Orthopedic

Jul 2004

Decision

25d

Days

Class 3

Risk

K041586 is an FDA 510(k) clearance for the PROFEMUR S HIP STEM. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III — Premarket Approval, product code JDL).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 9, 2004, 25 days after receiving the submission on June 14, 2004.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K041586 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2004
Decision Date	July 09, 2004
Days to Decision	25 days
Submission Type	Special
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