FDA 510(k)

Cranial COVER

K-Number: K160739 · 2016-06-12

Decision Date2016-06-12

Product CodeGXR

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cranial COVER is a medical device manufactured by Neos Surgery S.L. It received FDA 510(k) clearance on 2016-06-12 under approval number K160739. 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 Cranial COVER?

Cranial COVER is a medical device that received FDA 510(k) clearance on 2016-06-12. It is manufactured by Neos Surgery S.L. The 510(k) number is K160739.

When was Cranial COVER approved by the FDA?

Cranial COVER received FDA 510(k) clearance on 2016-06-12, under approval number K160739.

What company makes Cranial COVER?

Cranial COVER is manufactured by Neos Surgery S.L.

What is the FDA product code for Cranial COVER?

The FDA product code for Cranial COVER is GXR.

Other Devices by Neos Surgery S.L

K221795STERN FIX Sternal Stabilization System K211613Stern Fix Sternal Stabilization System K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

Related Devices (Code: GXR)

K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical K181539OSSDSIGN CranioplugOssdsign AB K181382GuardianTM Burr Hole Cover SystemSt Jude Medical K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.

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.