OPTIMUS NEURO SYSTEM

Plate, Cranioplasty, Preformed, Alterable

OSTEONIC CO., LTD.

The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Optimus Neuro System.

Pre-market Notification Details

Device IDK141911
510k NumberK141911
Device Name:OPTIMUS NEURO SYSTEM
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant OSTEONIC CO., LTD. 2651 E CHAPMAN AVE. STE 110 Fullerton,  CA  92831
ContactPriscilla Chung
CorrespondentPriscilla Chung
OSTEONIC CO., LTD. 2651 E CHAPMAN AVE. STE 110 Fullerton,  CA  92831
Product CodeGWO  
Subsequent Product CodeGXR
Subsequent Product CodeHBW
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-15
Decision Date2015-02-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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08809539691695 K141911 000

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