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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 K212414
Device Name OSSDSIGN Cranial PSI
Applicant
OssDsign AB
Rapsgatan 23A
Uppsala,  SE SE 754 50
Applicant Contact Ulrik Birgersson
Correspondent
David Weissburg
411 Walnut Street #16642
Green Cove Springs,  FL  32043 -3443
Correspondent Contact David Weissburg
Regulation Number882.5330
Classification Product Code
PJN  
Date Received08/03/2021
Decision Date 10/01/2021
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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