Filler, Bone Void, Non-alterable Compound For Cranioplasty

OssDsign AB

The following data is part of a premarket notification filed by Ossdsign Ab with the FDA for Ossdsign Cranial Psi.

Pre-market Notification Details

Device IDK212414
510k NumberK212414
Device Name:OSSDSIGN Cranial PSI
ClassificationFiller, Bone Void, Non-alterable Compound For Cranioplasty
Applicant OssDsign AB Rapsgatan 23A Uppsala,  SE Se 754 50
ContactUlrik Birgersson
CorrespondentDavid Weissburg
David Weissburg 411 Walnut Street #16642 Green Cove Springs,  FL  32043 -3443
Product CodePJN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-03
Decision Date2021-10-01

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