DePuy Synthes Variable Angle Locking Patella Plating System

Plate, Fixation, Bone

Synthes (USA) Products, LLC

The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes Variable Angle Locking Patella Plating System.

Pre-market Notification Details

Device IDK201578
510k NumberK201578
Device Name:DePuy Synthes Variable Angle Locking Patella Plating System
ClassificationPlate, Fixation, Bone
Applicant Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactEnrico Gindro
CorrespondentEnrico Gindro
Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2020-09-09

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