FDA.reportPublic FDA data

Surgical instrument handle, torque-limiting

Definition
A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.
GUDID devices
1,076
Last updated
2026-10-04 01:44:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858325005732GAUTHIER BIOMEDICALGAUTHIER BIOMEDICAL, INC.AR-9091-372026-09-22
10888857001299DENALI® MI Spinal SystemVB Spine LLC1001-901732021-04-08
10888857009820DENALI Spinal SystemVB Spine LLC101-900492022-07-25
10888857009844DENALI® Spinal SystemVB Spine LLC101-900512021-04-06
10888857009998DENALI Spinal SystemVB Spine LLC101-900942022-07-25
10888857010000DENALI Spinal SystemVB Spine LLC101-900952022-07-25
10888857010574DENALI Spinal SystemVB Spine LLC101-902132022-07-25
10888857010628DENALI Spinal SystemVB Spine LLC101-902192022-07-25
10888857016934CASPIAN Spinal SystemVB Spine LLC1101-900432022-08-08
10888857017016CASPIAN Spinal SystemVB Spine LLC1101-900532022-08-08
10888857017139CASPIAN Spinal SystemVB Spine LLC1101-901162022-08-08
10888857017788CASPIAN Spinal SystemVB Spine LLC1101-902462022-08-08
10888857019706CAYMAN Plate SystemVB Spine LLC1208-900292022-06-24
10888857029989PYRENEES Cervical Plate SystemVB Spine LLC201-900702022-06-17
10888857030299PYRENEES Cervical Plate SystemVB Spine LLC201-901402022-06-17
10888857033627CAPRI™ Corpectomy Cage SystemVB Spine LLC2112-900052021-04-05
10888857033696CAPRI Corpectomy Cage SystemVB Spine LLC2112-900122022-05-31
10888857040366EVEREST Spinal SystemVB Spine LLC2901-900762022-08-06
10888857040755EVEREST Spinal SystemVB Spine LLC2901-901332022-08-06
10888857052666MESA Small Stature Spinal SystemVB Spine LLC3001-900202022-08-06
10888857083424CHESAPEAKE® Stabilization SystemVB Spine LLC3608-901442021-04-06
10888857143289MESA Spinal SystemVB Spine LLC801-900672022-08-05
10888857143890MESA Spinal SystemVB Spine LLC801-901832022-08-05
10888857144019MESA Spinal SystemVB Spine LLC801-902062022-08-05
10888857157705EVEREST Spinal SystemVB Spine LLC2901-901342022-08-06
10888857177574DENALI Spinal SystemVB Spine LLC101-903532022-07-25
10888857186019EVEREST Spinal SystemVB Spine LLCK2-29-2011-012022-08-06
10888857198586SAHARA™ Stabilization SystemVB Spine LLC5808-900022016-05-20
10888857214903EVEREST® Spinal SystemVB Spine LLC5101-901322021-04-08
10888857242340CASPIAN Spinal SystemVB Spine LLCK2-11-2082-012022-08-08
10888857325982EVEREST® Spinal SystemVB Spine LLC5101-902212021-04-08
10888857352131MOJAVE Expandable Interbody SystemVB Spine LLC7012-900482022-06-01
10888857361898CAPRI™ Corpectomy Cage SystemVB Spine LLC7501-900272019-11-06
10888857378698OZARK Cervical Plate SystemVB Spine LLC8801-900312021-04-07
10888857384194YUKON OCT Spinal SystemVB Spine LLC7601-901382022-06-01
10888857398481MOJAVE Expandable Interbody SystemVB Spine LLC7012-901042022-06-01
10888857461277MOJAVE Expandable Interbody SystemVB Spine LLC7012-901142022-06-01
10888857462106YUKON OCT Spinal SystemVB Spine LLCSP-40582019-12-17
10888857481152OZARK Cervical Plate SystemVB Spine LLCSP-41772020-08-03
10888857524729K2M General InstrumentsVB Spine LLCPRO-10552021-07-20
10888857530539K2M General InstrumentsVB Spine LLCPRO-1126-022021-09-13
10888857554320K2M General InstrumentsVB Spine LLCPRO-12502022-07-29
10888857561779EVEREST Spinal SystemVB Spine LLCPRO-12572023-04-21
10888857578081Vulcan™ Spinal SystemVB Spine LLC8040-900122026-02-20
10888857579378K2M General InstrumentsVB Spine LLCPRO-1365-022024-07-08
10888857580282Vulcan™ Spinal SystemVB Spine LLC8040-900112026-02-20
00190837030964Pro Lift InstrumentsLife Spine, Inc.112-2222019-11-07
00817247023323MedTorqueArch Medical Solutions Corp.1TTL11-5NM-C112026-06-30
00817247023491MedTorqueArch Medical Solutions Corp.2TS5-C04-C082024-11-08
00817247024559MedTorqueArch Medical Solutions Corp.2TTL9-5NM-C112026-06-30
M719GL3110TiLockGenesys Orthopedics Systems LLC12026-08-03
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.33010-0002026-07-31
18257200146048FORZA XPOrthofix US LLC28-11322026-07-17
18257200148615FIREBIRD NXG POCTOrthofix US LLC36-16122026-07-17
008401944957693P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3100-10122026-06-10
008401944957763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3100-10132026-06-10
008401944958063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3100-10162026-06-10
00841732164178GENERIC Surgical InstrumentsCTL Medical Corporation50-5000-0282023-09-14
10855068008430Torque Limiting HandleCURVAFIX, INC.CTH-0022022-06-20
00190376032535ATEC InstrumentsALPHATEC SPINE, INC.86013-1200-0902020-06-17
00190376192468InvictusALPHATEC SPINE, INC.17093-0902020-06-17
00190376206974AMPALPHATEC SPINE, INC.86002-00172020-06-17
00190376217857ATEC InstrumentsALPHATEC SPINE, INC.17058-0402020-06-17
00190376692234IdentiTi IIALPHATEC SPINE, INC.86066-03002025-11-19
00190376706887InvictusALPHATEC SPINE, INC.17844-502026-04-09
00190376711492InvictusALPHATEC SPINE, INC.17844-402026-04-09
00810166520454X-PACEXPANDING INNOVATIONS, INC.EI46002026-05-01
00810166520461X-PACEXPANDING INNOVATIONS, INC.EI46012026-05-01
00810166520478X-PACEXPANDING INNOVATIONS, INC.EI46022026-05-01
00810166520522X-PACEXPANDING INNOVATIONS, INC.EI30642026-05-01
00810166521659X-PACEXPANDING INNOVATIONS, INC.EI26172026-05-01
00811801030062InvictusALPHATEC SPINE, INC.CI-100072020-09-19
00811801032882General InstrumentsALPHATEC SPINE, INC.CI-101752020-09-19
00811801034831General InstrumentsALPHATEC SPINE, INC.CI-102062020-09-19
00811801039966General InstrumentsALPHATEC SPINE, INC.CI-105912020-11-04
00822409099566n/aOrtho Development Corporation852-0010B2023-01-18
00840311251537Streamline® TL Spinal Fixation SystemXtant Medical Holdings, Inc.02-C-TORQUE2026-03-18
00840311251735Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.02-TL-HANDLE2026-04-30
00840311251780Streamline® TL Spinal Fixation SystemXtant Medical Holdings, Inc.02-XLNK-TLHANDLE2026-03-18
00840311258161SLIMFUSE ANTERIOR CERVICAL PLATE SYSTEMXtant Medical Holdings, Inc.21-CNTR-TRQ-INST2025-10-17