GXR · Class II · 21 CFR 882.5250

FDA Product Code GXR: Cover, Burr Hole

Leading manufacturers include Synthes (Usa), Neos Surgery S.L and Aesculap, Inc..

29
Total
29
Cleared
162d
Avg days
1985
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 165d avg (recent)

FDA 510(k) Cleared Cover, Burr Hole Devices (Product Code GXR)

29 devices
1–24 of 29
Cleared Mar 16, 2026
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
K253447
Orthocon, Inc.
Neurology · 165d
Cleared Feb 16, 2024
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
K240137
Neos Surgery S.L
Neurology · 29d
Cleared Nov 21, 2023
Absorbable Cranial Flap Fixation System
K221606
Chendu Medart Medical Scientific Co., Ltd.
Neurology · 537d
Cleared Jun 03, 2020
Flap Fixator, Burr Hole Cover
K192310
Ossaware Biotech Co., Ltd.
Neurology · 282d
Cleared Mar 13, 2020
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
K192162
Neurovention, LLC
Neurology · 217d
Cleared Oct 12, 2018
OSSDSIGN Cranioplug
K181539
Ossdsign AB
Neurology · 123d
Cleared Jul 20, 2018
GuardianTM Burr Hole Cover System
K181382
St Jude Medical
Neurology · 56d
Cleared Jun 12, 2016
Cranial COVER
K160739
Neos Surgery S.L
Neurology · 87d
Cleared Jun 09, 2016
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342
St Jude Medical
Neurology · 295d
Cleared Oct 03, 2014
CRANIOPLUG
K140309
Ossdsign AB
Neurology · 238d
Cleared Jul 11, 2014
NEUROPACE BURR HOLE COVER
K141368
NeuroPace, Inc.
Neurology · 49d
Cleared Sep 30, 2013
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
K132044
Neos Surgery S.L
Neurology · 90d
Cleared Aug 16, 2013
TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
K123633
Tissue Regeneration Systems, Inc.
Neurology · 266d
Cleared Jun 17, 2013
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309
Biomet Microfixation
Neurology · 130d
Cleared Jan 18, 2013
NEUROPACE BURR HOLE COVER MODEL 8110
K123163
NeuroPace, Inc.
Neurology · 101d
Cleared Aug 12, 2010
AESCULAP PEEK CRANIOFIX
K091692
Aesculap, Inc.
Neurology · 428d
Cleared Aug 15, 2007
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
K071138
Prosurg, Inc.
Neurology · 152d
Cleared Nov 17, 2004
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986
Synthes (Usa)
Orthopedic · 19d
Cleared Sep 08, 2004
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
K041611
Synthes (Usa)
Neurology · 85d
Cleared Mar 31, 2004
AESCULAP ABSORBABLE CRANIOFIX
K040080
Aesculap, Inc.
Neurology · 76d
Cleared Aug 08, 2003
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654
Synthes (Usa)
Neurology · 72d
Cleared Jul 29, 2002
RESORBABLE CRANIAL CLAMPS
K021408
Synthes (Usa)
Neurology · 87d
Cleared May 02, 2001
MACROPORENS CRANILOC
K002334
Macropore Biosurgery, Inc.
Neurology · 274d
Cleared Oct 25, 2000
BURR HOLE COVER, MODEL XX
K001096
Image-Guided Neurologics, Inc.
Neurology · 204d

About Product Code GXR - Regulatory Context

510(k) Submission Activity

29 total 510(k) submissions under product code GXR since 1985, with 29 receiving FDA clearance (average review time: 162 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - GXR Product Code

FDA review times for GXR submissions have been consistent, averaging 165 days recently vs 162 days historically.

GXR devices are reviewed by the Neurology panel. Browse all Neurology devices →