Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K190229
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 Received02/05/2019
Decision Date 07/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-