FDA 510(k)

OSSDSIGN Cranioplug

K-Number: K181539 · 2018-10-12

Decision Date2018-10-12

Product CodeGXR

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OSSDSIGN Cranioplug is a medical device manufactured by Ossdsign AB. It received FDA 510(k) clearance on 2018-10-12 under approval number K181539. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSDSIGN Cranioplug?

OSSDSIGN Cranioplug is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Ossdsign AB. The 510(k) number is K181539.

When was OSSDSIGN Cranioplug approved by the FDA?

OSSDSIGN Cranioplug received FDA 510(k) clearance on 2018-10-12, under approval number K181539.

What company makes OSSDSIGN Cranioplug?

OSSDSIGN Cranioplug is manufactured by Ossdsign AB.

What is the FDA product code for OSSDSIGN Cranioplug?

The FDA product code for OSSDSIGN Cranioplug is GXR.

Other Devices by Ossdsign AB

K161090Cranial PSI 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

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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.