DePuy Synthes 3.5/4.5 Mm Variable Angle LCP Periprosthetic Proximal Femur 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 3.5/4.5 Mm Variable Angle Lcp Periprosthetic Proximal Femur Plating System.

Pre-market Notification Details

Device IDK210205
510k NumberK210205
Device Name:DePuy Synthes 3.5/4.5 Mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
ClassificationPlate, Fixation, Bone
Applicant Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactSatapa Dhamankar
CorrespondentSatapa Dhamankar
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 Received2021-01-26
Decision Date2021-03-26

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