DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

Plate, 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 Craniomaxillofacial Sternal Devices - Mr Conditional.

Pre-market Notification Details

Device IDK190963
510k NumberK190963
Device Name:DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
ClassificationPlate, Fixation, Bone
Applicant Synthes (USA) Products LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactJeffrey Krawiec
CorrespondentJeffrey Krawiec
Synthes (USA) Products LLC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-12
Decision Date2019-07-23
Summary:summary

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