Atlas FDA

GXR

29 FDA 510(k) clearances · Product code

130 daysmedian time to decision
295 days90th percentile
29clearances measured

FDA profile

Official device name
Cover, Burr Hole
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5250
Medical specialty
Neurology
Flags
Implant
Adverse events (MAUDE)
2007: 3 · 2018: 45 · 2019: 28 · 2020: 16 · 2021: 28 · 2022: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (K253447)Orthocon, Inc.2026-03-16
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (K240137)Neos Surgery S.L2024-02-16
Absorbable Cranial Flap Fixation System (K221606)Chendu Medart Medical Scientific Co., Ltd.2023-11-21
Flap Fixator, Burr Hole Cover (K192310)Ossaware Biotech Co., Ltd.2020-06-03
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate (K192162)Neurovention, LLC2020-03-13
OSSDSIGN Cranioplug (K181539)Ossdsign AB2018-10-12
GuardianTM Burr Hole Cover System (K181382)St Jude Medical2018-07-20
Cranial COVER (K160739)Neos Surgery S.L2016-06-12
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (K152342)St Jude Medical2016-06-09
CRANIOPLUG (K140309)Ossdsign AB2014-10-03
NEUROPACE BURR HOLE COVER (K141368)NeuroPace, Inc.2014-07-11
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM (K132044)Neos Surgery S.L2013-09-30
TRS CRANIAL BONE VOID FILLER(TRS C-BVF) (K123633)Tissue Regeneration Systems, Inc.2013-08-16
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM (K130309)Biomet Microfixation2013-06-17
NEUROPACE BURR HOLE COVER MODEL 8110 (K123163)NeuroPace, Inc.2013-01-18
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM (K101235)Neos Surgery S.L2010-10-25
AESCULAP PEEK CRANIOFIX (K091692)Aesculap, Inc.2010-08-12
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM (K071138)Prosurg, Inc.2007-08-15
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM (K042986)Synthes (Usa)2004-11-17
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP (K041611)Synthes (Usa)2004-09-08
AESCULAP ABSORBABLE CRANIOFIX (K040080)Aesculap, Inc.2004-03-31
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) (K031654)Synthes (Usa)2003-08-08
RESORBABLE CRANIAL CLAMPS (K021408)Synthes (Usa)2002-07-29
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 (K010361)Medtronic PS Medical2001-05-07
MACROPORENS CRANILOC (K002334)Macropore Biosurgery, Inc.2001-05-02
BURR HOLE COVER, MODEL XX (K001096)Image-Guided Neurologics, Inc.2000-10-25
GORE BURR HOLE COVER (K960656)W. L. Gore & Associates, Inc.1996-08-14
PHOENIX BURR HOLE BUTTON, BURR 1 (K913490)Phoenix Bioengineering, Inc.1992-01-13
H-H BURR HOLE CATHETER SUPPORT (K853367)Holter-Hausner Intl.1985-09-11

Track GXR automatically

Every clearance here is in the API, with alerts when new ones post.