FDA.reportPublic FDA data

510(k) K240137

Device
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
Applicant
Neos Surgery S.L
510(k) number
K240137
Product code
GXR
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-16
Date received
2024-01-18
Regulation
882.5250
Classification name
Cover, Burr Hole
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eduard Garcia
Address
Ceramistes 2 Cerdanyola ES 08290 08290

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.2026-03-16
K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.2023-11-21
K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.2020-06-03
K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC2020-03-13
K181539OSSDSIGN CranioplugOssdsign AB2018-10-12
K181382GuardianTM Burr Hole Cover SystemSt Jude Medical2018-07-20
K160739Cranial COVERNeos Surgery S.L2016-06-12
K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical2016-06-09
K140309CRANIOPLUGOssdsign AB2014-10-03
K141368NEUROPACE BURR HOLE COVERNeuroPace, Inc.2014-07-11
K132044CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEMNeos Surgery S.L2013-09-30
K123633TRS CRANIAL BONE VOID FILLER(TRS C-BVF)Tissue Regeneration Systems, Inc.2013-08-16
K130309RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEMBiomet Microfixation2013-06-17
K123163NEUROPACE BURR HOLE COVER MODEL 8110NeuroPace, Inc.2013-01-18
K101235CRANIAL LOOP CRANIAL BONE FIXATION SYSTEMNeos Surgery S.L2010-10-25