Home / Device Classification / GXR

GXR — Cover, Burr Hole Class II

FDA Device Classification

Classification Details

Product Code
GXR
Device Class
Class II
Regulation Number
882.5250
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240137neos surgery s.lCranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemFebruary 16, 2024
K221606chendu medart medical scientific coAbsorbable Cranial Flap Fixation SystemNovember 21, 2023
K192310ossaware biotech coFlap Fixator, Burr Hole CoverJune 3, 2020
K192162neuroventionNeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlMarch 13, 2020
K181539ossdsignOSSDSIGN CranioplugOctober 12, 2018
K181382st jude medicalGuardianTM Burr Hole Cover SystemJuly 20, 2018
K160739neos surgery s.lCranial COVERJune 12, 2016
K152342st jude medicalGuardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverJune 9, 2016
K140309ossdsignCRANIOPLUGOctober 3, 2014
K141368neuropaceNEUROPACE BURR HOLE COVERJuly 11, 2014
K132044neos surgery s.lCRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTESeptember 30, 2013
K123633tissue regeneration systemsTRS CRANIAL BONE VOID FILLER(TRS C-BVF)August 16, 2013
K130309biomet microfixationRAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEMJune 17, 2013
K123163neuropaceNEUROPACE BURR HOLE COVER MODEL 8110January 18, 2013
K101235neos surgery s.lCRANIAL LOOP CRANIAL BONE FIXATION SYSTEMOctober 25, 2010
K091692aesculapAESCULAP PEEK CRANIOFIXAugust 12, 2010
K071138prosurgCRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEMAugust 15, 2007
K042986synthes (usa)MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEMNovember 17, 2004
K041611synthes (usa)SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMPSeptember 8, 2004
K040080aesculapAESCULAP ABSORBABLE CRANIOFIXMarch 31, 2004