Cover, Burr Hole
FDA product code GXR · 27 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.5250
- Review panel
- NE
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1985-09-11 – 2026-03-16
GXR
2026-03-16
GXR
2024-02-16
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
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GXR
2023-11-21
Absorbable Cranial Flap Fixation System
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GXR
2020-06-03
Flap Fixator, Burr Hole Cover
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GXR
2020-03-13
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
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GXR
2018-10-12
OSSDSIGN Cranioplug
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GXR
2018-07-20
GuardianTM Burr Hole Cover System
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GXR
2016-06-12
Cranial COVER
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GXR
2016-06-09
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
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GXR
2013-09-30
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
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GXR
2013-08-16
TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
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GXR
2013-06-17
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
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GXR
2013-01-18
NEUROPACE BURR HOLE COVER MODEL 8110
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GXR
2010-10-25
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
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GXR
2010-08-12
AESCULAP PEEK CRANIOFIX
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GXR
2007-08-15
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
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GXR
2004-11-17
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
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GXR
2004-09-08
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
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GXR
2004-03-31
AESCULAP ABSORBABLE CRANIOFIX
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GXR
2003-08-08
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
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GXR
2002-07-29
RESORBABLE CRANIAL CLAMPS
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GXR
2001-05-07
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
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GXR
2001-05-02
MACROPORENS CRANILOC
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GXR
2000-10-25
BURR HOLE COVER, MODEL XX
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GXR
1996-08-14
GORE BURR HOLE COVER
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GXR
1992-01-13
PHOENIX BURR HOLE BUTTON, BURR 1
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GXR
1985-09-11
H-H BURR HOLE CATHETER SUPPORT
View details →No matching devices.
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