Cranial COVER

FDA 510(k) K160739 · Neos Surgery S.L

Substantially Equivalent

510(k) numberK160739

Submission

Device name
Cranial COVER
Applicant
Neos Surgery S.L
Cerdanyola Del Valles, ES
Received
March 17, 2016
Decision date
June 12, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXR – Cover, Burr Hole
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5250
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code GXR

510(k)DeviceApplicantDecision
K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional Orthocon, Inc.03/16/2026SE
K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special Neos Surgery S.L02/16/2024SE
K221606Absorbable Cranial Flap Fixation SystemGXR · Traditional Chendu Medart Medical Scientific Co., Ltd.11/21/2023SE
K192310Flap Fixator, Burr Hole CoverGXR · Traditional Ossaware Biotech Co., Ltd.06/03/2020SE
K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateGXR · Traditional Neurovention, LLC03/13/2020SE
K181539OSSDSIGN CranioplugGXR · Traditional Ossdsign AB10/12/2018SE
K181382GuardianTM Burr Hole Cover SystemGXR · Abbreviated St Jude Medical07/20/2018SE
K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional St Jude Medical06/09/2016SE
K140309CranioplugGXR · Traditional Ossdsign AB10/03/2014SE
K141368Neuropace Burr Hole CoverGXR · Special NeuroPace, Inc.07/11/2014SE

More from NeuroPace, Inc.

510(k)DeviceDecision
K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special 02/16/2024SE
K221795STERN FIX Sternal Stabilization SystemJDQ · Traditional 10/19/2022SE
K211613Stern Fix Sternal Stabilization SystemJDQ · Traditional 01/19/2022SE
K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemGXR · Traditional 09/30/2013SE
K101235Cranial Loop Cranial Bone Fixation SystemGXR · Traditional 10/25/2010SE

Questions and answers

When was Cranial COVER cleared by the FDA?

Cranial COVER (K160739) received a 510(k) decision of Substantially Equivalent on June 12, 2016, 87 days after the submission was received.

What is the product code of K160739?

The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.