FDA.reportPublic FDA data

Trephining power tool attachment

Definition
A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to function as a craniotome when an appropriate cutter is inserted. It is inserted through a pre-drilled bur hole or perforator hole and is used to cut a flap in the bone of the skull vault (calvarium). It includes a small shielding tip at the distal end to prevent the end of the cutter penetrating the dura mater membrane. This is a reusable device.
GUDID devices
71
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05060528013482ZethonZETHON LIMITED1034802025-10-22
05060528013499ZethonZETHON LIMITED1034952025-10-22
05060528013505ZethonZETHON LIMITED1035082025-10-22
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SA16008792023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SA16008802023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SA16008872023-02-10
07630055505866Cranio Guard 10mm fixBien-Air Surgery SA16009122023-02-10
07630055505873Cranio Guard 15mm fixBien-Air Surgery SA16009132023-02-10
10381780152286Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION261402016-08-03
10381780152293Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-1412016-08-03
10381780152309Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-1422016-08-03
10381780152316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-1432016-08-03
10381780152323Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-162016-08-03
10381780152330Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-182016-08-03
10381780152347Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-22016-08-03
10381780152354Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-202016-08-03
10381780152392Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-33-32016-08-03
10381780152408Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-33-42016-08-03
10381780152422Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-12016-08-03
10381780152439Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-22016-08-03
10381780152446Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-32016-08-03
10381780152453Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-42016-08-03
10381780152460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-46-12016-08-03
10381780152477Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-46-22016-08-03
10381780152484Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION264632016-08-03
10381780152491Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-46-42016-08-03
J00716008790011Cranio Guard 15mm rotatingBien-Air Surgery SA16008792019-01-07
J00716008800011Cranio Guard 10mm rotatingBien-Air Surgery SA16008802019-01-07
J00716008870011Cranio Guard 25mm fixBien-Air Surgery SA16008872019-01-07
J00716009120011Cranio Guard 10mm fixBien-Air Surgery SA16009122019-01-07
J00716009130011Cranio Guard 15mm fixBien-Air Surgery SA16009132019-01-07
17630055505801Cranio Guard 15mm rotatingBien-Air Surgery SA16008792023-02-10
17630055505818Cranio Guard 10mm rotatingBien-Air Surgery SA16008802023-02-10
17630055505832Cranio Guard 25mm fixBien-Air Surgery SA16008872023-02-10
17630055505863Cranio Guard 10mm fixBien-Air Surgery SA16009122023-02-10
17630055505870Cranio Guard 15mm fixBien-Air Surgery SA16009132023-02-10
J00716008790Cranio Guard 15mm rotatingBien-Air Surgery SA16008792019-01-07
J00716008800Cranio Guard 10mm rotatingBien-Air Surgery SA16008802019-01-07
J00716008870Cranio Guard 25mm fixBien-Air Surgery SA16008872019-01-07
J00716009120Cranio Guard 10mm fixBien-Air Surgery SA16009122019-01-07
J00716009130Cranio Guard 15mm fixBien-Air Surgery SA16009132019-01-07
07611819798182NASynthes GmbH05.001.0592016-06-30
10381780152361Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-302016-08-03
10381780152415Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-402016-08-03
H834261401Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-1402016-08-03
H834261411Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-1412016-08-03
H834261421Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-1422016-08-03
H834261431Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-1432016-08-03
H83426161Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-162016-08-03
H83426181Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-182016-08-03
H83426201Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-202016-08-03
H8342621Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-22016-08-03
H834263331Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-33-32016-08-03
H834263341Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-33-42016-08-03
H834264411Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-12016-08-03
H834264421Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-22016-08-03
H834264441Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-42016-08-03
H834264611Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-46-12016-08-03
H834264621Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-46-22016-08-03
H834264631Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-46-32016-08-03
H834264641Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-46-42016-08-03
10381780152378Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-33-12016-08-30
10381780152385Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-33-22016-08-30
H834264431Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION26-44-32016-08-03
00845384001744NAAnspach Effort, TheCRANI-A-R2018-02-05
00845384001751NASynthes GmbHCRANI-L2018-02-05
00845384001768NAAnspach Effort, TheCRANI-L-R2018-02-05
00845384001775NASynthes GmbHCRANI-P2018-02-05
00845384016403NASynthes GmbHCRANI-P-G12016-09-09
00845384016410NASynthes GmbHCRANI-A-G12016-09-09
00845384016427NASynthes GmbHCRANI-L-G12016-09-09