Cleared Special

4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM

K110354 · Synthes (Usa) · Orthopedic

Mar 2011

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K110354 is an FDA 510(k) clearance for the 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM, a Condylar Plate Fixation Implant (Class II — Special Controls, product code JDP), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on March 4, 2011, 25 days after receiving the submission on February 7, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K110354 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2011
Decision Date	March 04, 2011
Days to Decision	25 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF