Stryker PEEK Customized Cranial Implant Kit

Plate, Cranioplasty, Preformed, Alterable

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Peek Customized Cranial Implant Kit.

Pre-market Notification Details

Device IDK190229
510k NumberK190229
Device Name:Stryker PEEK Customized Cranial Implant Kit
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant Stryker 750 Trade Centre Way - Suite 200 Portage,  MI  49002
ContactZainab Amini
CorrespondentZainab Amini
Stryker 750 Trade Centre Way - Suite 200 Portage,  MI  49002
Product CodeGWO  
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-05
Decision Date2019-07-11

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