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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, cranioplasty, preformed, alterable
510(k) Number K203055
Device Name Stryker PEEK Customized Cranial Implant Kit
Applicant
Stryker
750 Trade Centre Way - Suite 200
Portage,  MI  49002
Applicant Contact Zainab Amini
Correspondent
Stryker
750 Trade Centre Way - Suite 200
Portage,  MI  49002
Correspondent Contact Zainab Amini
Regulation Number882.5320
Classification Product Code
GWO  
Date Received10/08/2020
Decision Date 02/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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