DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws For Medullary Nails, 5.0 Mm

Rod, Fixation, Intramedullary And Accessories

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 Retrograde Femoral Nail Advanced System, Depuy Synthes Locking Screws For Medullary Nails, 5.0 Mm.

Pre-market Notification Details

Device IDK201346
510k NumberK201346
Device Name:DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws For Medullary Nails, 5.0 Mm
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactKeith Knapp
CorrespondentKeith Knapp
Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-21
Decision Date2020-09-23

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