FDA.reportPublic FDA data

Stereotactic radiosurgical invasive head frame

Definition
A device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable device.
GUDID devices
681
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858086006283Head Frame Cranial Screws - Long and ShortVARIAN MEDICAL SYSTEMS, INC.P10068010062021-01-16
00899475002165Cranial Screw - Short/LongVARIAN MEDICAL SYSTEMS, INC.P10068010032016-09-16
00899475002370VARIAN HEAD FRAMEVARIAN MEDICAL SYSTEMS, INC.2.02018-05-15
00899475002387VARIAN HEAD FRAME PACKAGEVARIAN MEDICAL SYSTEMS, INC.2.02018-05-15
00899475002493Varian POST ASSY, STEREOTACTIC HEAD FRAMEVARIAN MEDICAL SYSTEMS, INC.100027385032021-02-19
00899475002950Not in useVARIAN MEDICAL SYSTEMS, INC.1162025-10-17
00899475002967Not in useVARIAN MEDICAL SYSTEMS, INC.962025-10-17
00899475002974Not in useVARIAN MEDICAL SYSTEMS, INC.972025-10-17
00899475002981Not in useVARIAN MEDICAL SYSTEMS, INC.982025-10-17
00899475002998Not in useVARIAN MEDICAL SYSTEMS, INC.992025-10-17
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONDHRSL52017-04-14
10381780210856CRW®INTEGRA LIFESCIENCES CORPORATIONMRCTF22016-07-26
10381780210870CRW®INTEGRA LIFESCIENCES CORPORATIONNBND2016-07-26
10381780251330CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPRECISE2016-07-26
10381780251347CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPBSRAID2016-07-26
10381780251354CRW®INTEGRA LIFESCIENCES CORPORATIONCRWRAID2016-07-26
10381780251361CRW® PrecisionINTEGRA LIFESCIENCES CORPORATIONCRWPGB2016-07-26
10381780251378CRW®INTEGRA LIFESCIENCES CORPORATIONCRWFASP2016-07-26
10381780251385Integra®INTEGRA LIFESCIENCES CORPORATIONGT27762016-07-26
10381780251392Integra®INTEGRA LIFESCIENCES CORPORATIONGT271162016-07-26
10381780251408Integra®INTEGRA LIFESCIENCES CORPORATIONRB272016-07-26
10381780251439Integra®INTEGRA LIFESCIENCES CORPORATIONDA272016-07-26
10381780251446Integra®INTEGRA LIFESCIENCES CORPORATIONKDG2016-07-26
10381780251460CRW®INTEGRA LIFESCIENCES CORPORATIONCRWASL2016-07-26
10381780251477CRW®INTEGRA LIFESCIENCES CORPORATIONCRWASGB2016-07-26
10381780251484Integra®INTEGRA LIFESCIENCES CORPORATIONSWTS2016-07-26
10381780251507CRW®INTEGRA LIFESCIENCES CORPORATIONCRWMA2016-07-26
10381780251514CRW®INTEGRA LIFESCIENCES CORPORATIONCRWASP2016-07-26
10381780251521CRW®INTEGRA LIFESCIENCES CORPORATIONBRWASPW2016-07-26
10381780251538CRW®INTEGRA LIFESCIENCES CORPORATIONCRWMS2016-07-26
10381780251545CRW®INTEGRA LIFESCIENCES CORPORATIONCRWP302016-07-26
10381780251552CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPMDD2016-07-26
10381780251569Integra®INTEGRA LIFESCIENCES CORPORATIONDA322016-07-26
10381780251576Integra®INTEGRA LIFESCIENCES CORPORATIONDA462016-07-26
10381780251583CRW®INTEGRA LIFESCIENCES CORPORATIONDA632016-07-26
10381780251606Integra®INTEGRA LIFESCIENCES CORPORATIONGT271602016-07-26
10381780251613Integra®INTEGRA LIFESCIENCES CORPORATIONGT321162016-07-26
10381780251620Integra®INTEGRA LIFESCIENCES CORPORATIONGT321602016-07-26
10381780251637Integra®INTEGRA LIFESCIENCES CORPORATIONGT32762016-07-26
10381780251644Integra®INTEGRA LIFESCIENCES CORPORATIONGT461162016-07-26
10381780251651CRW®INTEGRA LIFESCIENCES CORPORATIONRT071162016-07-26
10381780251668CRW®INTEGRA LIFESCIENCES CORPORATIONRT07762016-07-26
10381780251675Integra®INTEGRA LIFESCIENCES CORPORATIONRT111162016-07-26
10381780251682Integra®INTEGRA LIFESCIENCES CORPORATIONRT11762016-07-26
10381780251699Integra®INTEGRA LIFESCIENCES CORPORATIONRT161162016-07-26
10381780251705Integra®INTEGRA LIFESCIENCES CORPORATIONRT16762016-07-26
10381780251712Integra®INTEGRA LIFESCIENCES CORPORATIONRT18762016-07-26
10381780251729Integra®INTEGRA LIFESCIENCES CORPORATIONRT181162016-07-26
10381780251736CRW®INTEGRA LIFESCIENCES CORPORATIONRT201602016-07-26
10381780251743Integra®INTEGRA LIFESCIENCES CORPORATIONRT201162016-07-26
10381780251750Integra®INTEGRA LIFESCIENCES CORPORATIONRT20762016-07-26
10381780251767Integra®INTEGRA LIFESCIENCES CORPORATIONRT211162016-07-26
10381780251774Integra®INTEGRA LIFESCIENCES CORPORATIONRT21762016-07-26
10381780251781CRW®INTEGRA LIFESCIENCES CORPORATIONRT251162016-07-26
10381780251798CRW®INTEGRA LIFESCIENCES CORPORATIONRT25762016-07-26
10381780251828CRW®INTEGRA LIFESCIENCES CORPORATIONCRWAPBS2016-07-26
10381780251835CRW®INTEGRA LIFESCIENCES CORPORATIONCRWMCPH302016-07-26
10381780251842CRW®INTEGRA LIFESCIENCES CORPORATIONCRWFMA2016-07-26
10381780251859CRW®INTEGRA LIFESCIENCES CORPORATIONSDK2016-07-26
10381780251897CRW®INTEGRA LIFESCIENCES CORPORATIONGSKSS202016-07-26
10381780251903CRW®INTEGRA LIFESCIENCES CORPORATIONGSKSS252202016-07-26
10381780251910CRW®INTEGRA LIFESCIENCES CORPORATIONGSKSS302102016-07-26
10381780251927CRW®INTEGRA LIFESCIENCES CORPORATIONCRWHK2016-07-26
10381780251934CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPBSHK2016-07-26
10381780251958CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPMDB162016-07-26
10381780251965CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPMDB202016-07-26
10381780251972CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPMDB252016-07-26
10381780251989CRW®INTEGRA LIFESCIENCES CORPORATIONCRWPMDB302016-07-26
10381780251996CRW®INTEGRA LIFESCIENCES CORPORATIONCRWTBSS2016-07-26
10381780252009CRW®INTEGRA LIFESCIENCES CORPORATIONCSL2016-07-26
10381780252016CRW®INTEGRA LIFESCIENCES CORPORATIONCSS2016-07-26
10381780252023Integra®INTEGRA LIFESCIENCES CORPORATIONDA27D2016-07-26
10381780252030Integra®INTEGRA LIFESCIENCES CORPORATIONDA32D2016-07-26
10381780252047Integra®INTEGRA LIFESCIENCES CORPORATIONDA46D2016-07-26
10381780252054CRW®INTEGRA LIFESCIENCES CORPORATIONDA63D2016-07-26
10381780252085CRW®INTEGRA LIFESCIENCES CORPORATIONDADS272016-07-26
10381780252092CRW®INTEGRA LIFESCIENCES CORPORATIONDADS322016-07-26
10381780252108CRW®INTEGRA LIFESCIENCES CORPORATIONDADS462016-07-26
10381780252115CRW®INTEGRA LIFESCIENCES CORPORATIONDADS632016-07-26
10381780252122CRW®INTEGRA LIFESCIENCES CORPORATIONDS182016-07-26