Holder, Head, Neurosurgical (Skull Clamp)
FDA product code HBL · 48 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.4460
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1982-09-28 – 2025-11-06
HBL
2025-11-06
HBL
2024-07-26
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
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HBL
2024-04-24
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
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HBL
2021-03-29
DORO QR3 Headrest System (Aluminum)
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HBL
2020-06-02
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
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HBL
2020-02-21
DORO LUCENT® iXI and iMRI Headrest System
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HBL
2019-11-15
Arcus Head Fixation Frame
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HBL
2019-10-22
DORO QR3 XTom Headholder System
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HBL
2017-02-23
TZ SKULL PIN Adult
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HBL
2013-04-26
STERILE RADIOLUCENT SKULL PINS
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HBL
2013-04-23
MAYFIELD INFINITY XR2 SKULL CLAMP
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HBL
2012-05-24
MAYFIELD SKULL CLAMP
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HBL
2012-03-23
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
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HBL
2011-03-11
HEAD FIATION DEVICE (HFD 100)
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HBL
2010-03-10
FIXIT HEADREST CLAMP SYSTEM
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HBL
2009-08-25
HEAD FIXATION ARC AND TABLE BASE
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HBL
2009-04-23
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
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HBL
2009-04-20
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
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HBL
2008-10-08
MAYFIELD MR/X-RAY SKULL CLAMP
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HBL
2008-02-28
LIMITED ARTIFACT SKULL PIN, MODEL 0107
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HBL
2007-09-07
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
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HBL
2007-06-13
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
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HBL
2007-05-21
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
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HBL
2005-11-21
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
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HBL
2005-09-20
MAYFIELD INFINITY SKULL CLAMP
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HBL
2005-03-31
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
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HBL
2003-11-20
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
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HBL
2003-08-21
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
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HBL
2002-07-29
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
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HBL
2000-11-06
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
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HBL
2000-08-29
PSI SKULL CLAMP
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HBL
2000-08-04
DORO HEADREST SYSTEM
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HBL
1996-09-12
MIZUHO RADIOLUCENT HEAD FRAME
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HBL
1996-02-09
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
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HBL
1995-12-06
MAYFIELD CHILD DISPOSABLE SKULL PIN
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HBL
1994-01-07
MAYFIELD RADIOLUCENT SKULL CLAMP
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HBL
1993-09-28
MAYFIELD ADULT DISPOSABLE SKULL PIN
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HBL
1993-09-28
MAYFIELD* A-2000 SKULL CLAMP
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HBL
1993-02-12
MAYFIELD ADULT DISPOSABLE SKULL PIN
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HBL
1991-09-19
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
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HBL
1991-09-10
CODMAN DISPOSABLE SKULL PINS
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HBL
1991-09-06
CODMAN SKULL CLAMP
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HBL
1991-08-26
GARDNER PINS (ADULT & CHILD)
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HBL
1991-07-31
CODMAN SKULL CLAMP
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HBL
1990-09-04
MAINZ HEAD FIXATION BY PERNECZKY
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HBL
1989-08-29
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
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HBL
1988-02-04
MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
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HBL
1982-09-28
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR
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