DePuy Synthes Hammertoe Continuous Compression Implant

Staple, 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 Hammertoe Continuous Compression Implant.

Pre-market Notification Details

Device IDK191463
510k NumberK191463
Device Name:DePuy Synthes Hammertoe Continuous Compression Implant
ClassificationStaple, Fixation, Bone
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 CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2020-02-26

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