Cleared Special

DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER

K061844 · Wrightmedicaltechnologyinc · Orthopedic

Dec 2006

Decision

160d

Days

Class 3

Risk

About This 510(k) Submission

K061844 is an FDA 510(k) clearance for the DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER, 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 December 6, 2006, 160 days after receiving the submission on June 29, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K061844 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2006
Decision Date	December 06, 2006
Days to Decision	160 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