FDA 510(k) Applications for Medical Device Product Code "HBL"
(Holder, Head, Neurosurgical (Skull Clamp))

FDA 510(k) Number Applicant Device Name Decision Date
K122225 BRAINLAB AG STERILE RADIOLUCENT SKULL PINS 04/26/2013
K911723 CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE SKULL PINS 09/10/1991
K912011 CODMAN & SHURTLEFF, INC. CODMAN SKULL CLAMP 07/31/1991
K913170 CODMAN & SHURTLEFF, INC. CODMAN SKULL CLAMP 09/06/1991
K912005 CODMAN & SHURTLEFF, INC. CODMAN SKULL PINS (ADULT & CHILD), REUSABLE 09/19/1991
K911772 CODMAN & SHURTLEFF, INC. GARDNER PINS (ADULT & CHILD) 08/26/1991
K090695 DINKLER SURGICAL DEVICES, INC. DINKLER SURGICAL SKULL CLAMP, MODEL 0308 04/23/2009
K073163 DINKLER SURGICAL DEVICES, INC. LIMITED ARTIFACT SKULL PIN, MODEL 0107 02/28/2008
K821772 DOWNS SURGICAL LTD. SURGITA/MIZHO MICRONEUROSURGERY HEAD FR 09/28/1982
K874298 ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC. MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME 02/04/1988
K031885 IMAGE-GUIDED NEUROLOGICS, INC. NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX 08/21/2003
K103493 IMRIS, INC. HEAD FIATION DEVICE (HFD 100) 03/11/2011
K141950 IMRIS, INC. HFD100 ROCKER ARM ACCESSORY 09/04/2014
K113748 IMRIS, INC. IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) 03/23/2012
K051440 INTEGRA LIFESCIENCES CORP. MAYFIELD INFINITY SKULL CLAMP 09/20/2005
K050319 INTEGRA LIFESCIENCES CORP. MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 03/31/2005
K081401 INTEGRA LIFESCIENCES CORP. MAYFIELD MR/X-RAY SKULL CLAMP 10/08/2008
K072208 INTEGRA LIFESCIENCES CORPORATION MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS 09/07/2007
K130389 INTEGRA LIFESCIENCES CORPORATION MAYFIELD INFINITY XR2 SKULL CLAMP 04/23/2013
K090506 INTEGRA LIFESCIENCES CORPORATION MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 04/20/2009
K071458 INTEGRA LIFESCIENCES CORPORATION MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 06/13/2007
K120633 INTEGRA LIFESCIENCES CORPORATION MAYFIELD SKULL CLAMP 05/24/2012
K142238 INTEGRA LIFESCIENCES CORPORATION MAYFIELD Skull Clamp 11/24/2014
K053045 INTEGRA LIFESCIENCES CORPORATION MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 11/21/2005
K893911 MEDICAL EQUIPMENT DEVELOPMENT CO., INC. MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM 08/29/1989
K083803 MEDICON, E.G. FIXIT HEADREST CLAMP SYSTEM 03/10/2010
K955012 MIZUHO AMERICA, INC. MIZUHO RADIOLUCENT HEAD FRAME 09/12/1996
K923789 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD ADULT DISPOSABLE SKULL PIN 02/12/1993
K932860 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD ADULT DISPOSABLE SKULL PIN 09/28/1993
K941558 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD CHILD DISPOSABLE SKULL PIN 12/06/1995
K953124 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD RADIOLUCENT 2000 SKULL CLAMP 02/09/1996
K934289 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD RADIOLUCENT SKULL CLAMP 01/07/1994
K021604 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 07/29/2002
K932807 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD* A-2000 SKULL CLAMP 09/28/1993
K001808 PRO-MED INSTRUMENTS GMBH DORO HEADREST SYSTEM 08/04/2000
K063494 PRO-MED INSTRUMENTS GMBH DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS 05/21/2007
K032331 PRO-MED INSTRUMENTS GMBH DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) 11/20/2003
K091439 SURGIVISION, INC. HEAD FIXATION ARC AND TABLE BASE 08/25/2009
K163322 TZ MEDICAL INC TZ SKULL PIN Adult 02/23/2017
K002276 V. MUELLER NEURO/SPINE PSI SKULL CLAMP 08/29/2000
K002990 VASCULAR TECHNOLOGY INCORPORATED VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 11/06/2000
K901393 ZEPPELIN GMBH MAINZ HEAD FIXATION BY PERNECZKY 09/04/1990


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