PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority

Plate, Cranioplasty, Preformed, Alterable

Stryker

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

Pre-market Notification Details

Device IDK152076
510k NumberK152076
Device Name:PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant Stryker 750 TRADE CENTRE WAY SUITE 200 Portage,  MI  49002
ContactJonathan Schell
CorrespondentJonathan Schell
Stryker 750 TRADE CENTRE WAY SUITE 200 Portage,  MI  49002
Product CodeGWO  
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-27
Decision Date2015-08-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327129335 K152076 000
07613327300048 K152076 000
07613327300123 K152076 000
07613327300031 K152076 000
07613327300055 K152076 000
07613327300079 K152076 000
07613327300086 K152076 000
07613327300109 K152076 000
07613327129236 K152076 000
07613327129243 K152076 000
07613327129250 K152076 000
07613327129267 K152076 000
07613327129274 K152076 000
07613327129281 K152076 000
07613327129298 K152076 000
07613327129304 K152076 000
07613327129328 K152076 000
07613327300017 K152076 000

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