DePuy Synthes Trauma Screws

Screw, Fixation, Bone

Synthes (USA) Products LLC / DePuy Orthopaedics Inc

The following data is part of a premarket notification filed by Synthes (usa) Products Llc / Depuy Orthopaedics Inc with the FDA for Depuy Synthes Trauma Screws.

Pre-market Notification Details

Device IDK192745
510k NumberK192745
Device Name:DePuy Synthes Trauma Screws
ClassificationScrew, Fixation, Bone
Applicant Synthes (USA) Products LLC / DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester,  PA  19380
ContactKeith Knapp
CorrespondentKeith Knapp
Synthes (USA) Products LLC / DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester,  PA  19380
Product CodeHWC  
Subsequent Product CodeHRS
Subsequent Product CodeHTN
Subsequent Product CodeHTY
Subsequent Product CodeJDS
Subsequent Product CodeJDW
Subsequent Product CodeKTT
Subsequent Product CodeNDG
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-11-26
Summary:summary

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