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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2020-02-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810633022054 K191463 000
00810633022047 K191463 000

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