Cleared Special

DYNASTY ACETABULAR SYSTEM

K070785 · Wrightmedicaltechnologyinc · Orthopedic

Jul 2007

Decision

112d

Days

Class 3

Risk

About This 510(k) Submission

K070785 is an FDA 510(k) clearance for the DYNASTY ACETABULAR SYSTEM, 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 11, 2007, 112 days after receiving the submission on March 21, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K070785 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2007
Decision Date	July 11, 2007
Days to Decision	112 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