Cleared Traditional

Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins

K162124 · DePuy Synthes · Orthopedic

Mar 2017

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K162124 is an FDA 510(k) clearance for the Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins, a Condylar Plate Fixation Implant (Class II — Special Controls, product code JDP), submitted by DePuy Synthes (19380, US). The FDA issued a Cleared decision on March 29, 2017, 240 days after receiving the submission on August 1, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K162124 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2016
Decision Date	March 29, 2017
Days to Decision	240 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF