FDA Product Code GXR: Cover, Burr Hole
Leading manufacturers include Neos Surgery S.L and Orthocon, 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
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
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 Review Time
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 →