DePuy Synthes Static Staples

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 Static Staples.

Pre-market Notification Details

Device IDK180544
510k NumberK180544
Device Name:DePuy Synthes Static Staples
ClassificationStaple, Fixation, Bone
Applicant Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactSuchitra Basu
CorrespondentSuchitra Basu
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 Received2018-03-01
Decision Date2018-07-24
Summary:summary

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