DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 And 5.0mm

Nail, 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 Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 And 5.0mm.

Pre-market Notification Details

Device IDK201336
510k NumberK201336
Device Name:DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 And 5.0mm
ClassificationNail, Fixation, Bone
Applicant Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactPol Fort Grebol
CorrespondentPol Fort Grebol
Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeJDS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-09-03

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