DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

Plate, Cranioplasty, Preformed, Non-alterable

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 Neuro Devices - Mr Conditional.

Pre-market Notification Details

Device IDK192702
510k NumberK192702
Device Name:DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
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 CodeGXN  
Subsequent Product CodeDZL
Subsequent Product CodeGWO
Subsequent Product CodeGXR
Subsequent Product CodeJEY
Subsequent Product CodeMQN
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2020-09-18

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