Cleared Traditional

CONSERVE TOTAL FEMORAL HEAD

K051348 · Wrightmedicaltechnologyinc · Orthopedic

Aug 2005

Decision

87d

Days

Class 3

Risk

About This 510(k) Submission

K051348 is an FDA 510(k) clearance for the CONSERVE TOTAL FEMORAL HEAD, 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 August 19, 2005, 87 days after receiving the submission on May 24, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K051348 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2005
Decision Date	August 19, 2005
Days to Decision	87 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