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 IDK210408
510k NumberK210408
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 Received2021-02-11
Decision Date2021-04-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886982291943 K210408 000
10886982291936 K210408 000
10886982291929 K210408 000
10886982291912 K210408 000

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