FDA 510(k)

Cranial PSI

K-Number: K161090 · 2017-01-19

Decision Date2017-01-19

Product CodeGXN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cranial PSI is a medical device manufactured by Ossdsign AB. It received FDA 510(k) clearance on 2017-01-19 under approval number K161090. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cranial PSI?

Cranial PSI is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Ossdsign AB. The 510(k) number is K161090.

When was Cranial PSI approved by the FDA?

Cranial PSI received FDA 510(k) clearance on 2017-01-19, under approval number K161090.

What company makes Cranial PSI?

Cranial PSI is manufactured by Ossdsign AB.

What is the FDA product code for Cranial PSI?

The FDA product code for Cranial PSI is GXN.

Other Devices by Ossdsign AB

K181539OSSDSIGN Cranioplug K190523Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial K212414OSSDSIGN Cranial PSI K232315Catalyst Bone Void Filler

Related Devices (Code: GXN)

K160707CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K171507CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. K180513CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.