HBL · Class II · 21 CFR 882.4460

FDA Product Code HBL: Holder, Head, Neurosurgical (skull Clamp)

Leading manufacturers include Pro-Med Instruments GmbH, Ohio Medical Instrument Co., Inc. and Integra LifeSciences Corporation.

51
Total
51
Cleared
128d
Avg days
1982
Since
51 devices
25–48 of 51
Cleared Jun 13, 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458
Integra LifeSciences Corporation
Neurology · 19d
Cleared May 21, 2007
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
K063494
Pro-Med Instruments GmbH
Neurology · 182d
Cleared Nov 21, 2005
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045
Integra LifeSciences Corporation
Neurology · 24d
Cleared Sep 20, 2005
MAYFIELD INFINITY SKULL CLAMP
K051440
Integra Lifesciences Corp.
Neurology · 110d
Cleared Mar 31, 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319
Integra Lifesciences Corp.
Neurology · 50d
Cleared Nov 20, 2003
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
K032331
Pro-Med Instruments GmbH
Neurology · 114d
Cleared Aug 21, 2003
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885
Image-Guided Neurologics, Inc.
Neurology · 64d
Cleared Jul 29, 2002
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K021604
Ohio Medical Instrument Co., Inc.
Neurology · 74d
Cleared Nov 06, 2000
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000
K002990
Vascular Technology Incorporated
Neurology · 42d
Cleared Aug 29, 2000
PSI SKULL CLAMP
K002276
V. Mueller Neuro/Spine
Neurology · 34d
Cleared Aug 04, 2000
DORO HEADREST SYSTEM
K001808
Pro-Med Instruments GmbH
Neurology · 50d
Cleared Sep 12, 1996
MIZUHO RADIOLUCENT HEAD FRAME
K955012
Mizuho America, Inc.
Neurology · 316d
Cleared Feb 09, 1996
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
K953124
Ohio Medical Instrument Co., Inc.
Neurology · 219d
Cleared Dec 06, 1995
MAYFIELD CHILD DISPOSABLE SKULL PIN
K941558
Ohio Medical Instrument Co., Inc.
Neurology · 615d
Cleared Jan 07, 1994
MAYFIELD RADIOLUCENT SKULL CLAMP
K934289
Ohio Medical Instrument Co., Inc.
Neurology · 127d
Cleared Sep 28, 1993
MAYFIELD* A-2000 SKULL CLAMP
K932807
Ohio Medical Instrument Co., Inc.
Neurology · 111d
Cleared Sep 28, 1993
MAYFIELD ADULT DISPOSABLE SKULL PIN
K932860
Ohio Medical Instrument Co., Inc.
Neurology · 109d
Cleared Feb 12, 1993
MAYFIELD ADULT DISPOSABLE SKULL PIN
K923789
Ohio Medical Instrument Co., Inc.
Neurology · 199d
Cleared Sep 19, 1991
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
K912005
Codman & Shurtleff, Inc.
Neurology · 136d
Cleared Sep 10, 1991
CODMAN DISPOSABLE SKULL PINS
K911723
Codman & Shurtleff, Inc.
Neurology · 146d
Cleared Sep 06, 1991
CODMAN SKULL CLAMP
K913170
Codman & Shurtleff, Inc.
Neurology · 51d
Cleared Aug 26, 1991
GARDNER PINS (ADULT & CHILD)
K911772
Codman & Shurtleff, Inc.
Neurology · 129d
Cleared Jul 31, 1991
CODMAN SKULL CLAMP
K912011
Codman & Shurtleff, Inc.
Neurology · 86d
Cleared Sep 04, 1990
MAINZ HEAD FIXATION BY PERNECZKY
K901393
Zeppelin GmbH
Neurology · 162d