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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Non-Alterable Compound For Cranioplasty
510(k) Number K190523
Device Name Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
Applicant
Ossdsign AB
Virdings Alle 2
Uppsala,  SE SE 754 50
Applicant Contact Ulrik Birgersson
Correspondent
Weissburg Associates
300 2nd Ave. SE, #14
St. Petersburg,  FL  33701
Correspondent Contact David Weissburg
Regulation Number882.5330
Classification Product Code
PJN  
Date Received03/04/2019
Decision Date 10/10/2019
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
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