FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K122225 |
BRAINLAB AG |
STERILE RADIOLUCENT SKULL PINS |
04/26/2013 |
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 |
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 |
K083803 |
MEDICON, E.G. |
FIXIT HEADREST CLAMP SYSTEM |
03/10/2010 |
K955012 |
MIZUHO AMERICA, INC. |
MIZUHO RADIOLUCENT HEAD FRAME |
09/12/1996 |
K191701 |
MRI Interventions, Inc. |
Arcus Head Fixation Frame |
11/15/2019 |
K953124 |
OHIO MEDICAL INSTRUMENT CO., INC. |
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP |
02/09/1996 |
K021604 |
OHIO MEDICAL INSTRUMENT CO., INC. |
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
07/29/2002 |
K191740 |
Pro Med Instruments GmbH |
DORO LUCENT« iXI and iMRI Headrest System |
02/21/2020 |
K203505 |
pro med instruments GmbH |
DORO QR3 Headrest System (Aluminum) |
03/29/2021 |
K191979 |
Pro Med Instruments GmbH |
DORO QR3 XTom Headholder System |
10/22/2019 |
K193438 |
Pro Med Instruments GmbH |
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) |
06/02/2020 |
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 |