FDA Product Code GXR: Cover, Burr Hole
Leading manufacturers include Synthes (Usa), St Jude Medical and Ossdsign AB.
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
Cleared
Mar 16, 2026
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
Orthocon, Inc.
Neurology
165d
Cleared
Feb 16, 2024
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
Neos Surgery S.L
Neurology
29d
Cleared
Nov 21, 2023
Absorbable Cranial Flap Fixation System
Chendu Medart Medical Scientific Co., Ltd.
Neurology
537d
Cleared
Jun 03, 2020
Flap Fixator, Burr Hole Cover
Ossaware Biotech Co., Ltd.
Neurology
282d
Cleared
Mar 13, 2020
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
Neurovention, LLC
Neurology
217d
Cleared
Oct 12, 2018
OSSDSIGN Cranioplug
Ossdsign AB
Neurology
123d
Cleared
Jul 20, 2018
GuardianTM Burr Hole Cover System
St Jude Medical
Neurology
56d
Cleared
Nov 17, 2004
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
Synthes (Usa)
Orthopedic
19d
Cleared
Sep 08, 2004
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
Synthes (Usa)
Neurology
85d
Cleared
Aug 08, 2003
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
Synthes (Usa)
Neurology
72d
Cleared
Jul 29, 2002
RESORBABLE CRANIAL CLAMPS
Synthes (Usa)
Neurology
87d
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 →