FDA.reportPublic FDA data

Surgical instrument torque limiter

Definition
A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. 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
119
Last updated
2026-06-11 06:06:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613327648331PANGEAStryker GmbH5421602026-06-02
07613327648362PANGEAStryker GmbH5421612026-06-02
00841435111257TecometTECOMET INC.01-09-30352026-04-10
04042409196348NAaap Implantate AGIU 7870-082018-02-28
04042409262227NAaap Implantate AGIU 7707-152018-02-28
04042409262234NAaap Implantate AGIU 7707-202018-02-28
04042409262241NAaap Implantate AGIU 7707-352018-02-28
04042409282027NAaap Implantate AGIU 7707-002018-02-28
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGB-4100142025-10-17
08032909629923ST.A.R. 90 F4CITIEFFE SRLTorque wrench2016-09-29
08052990970599PL8CITIEFFE SRLTorque limiting handle, screws ø2.5mm2018-09-01
08806390876186Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationSO-111-TD-0302019-02-14
10381780245261Integra®Ascension Orthopedics, Inc.G2071532017-08-30
10705034711522NASynthes GmbH03.110.002.992016-12-31
10812269020012Torque Limiter T-HandleMIAMI DEVICE SOLUTIONS LLCMDS000602AOT2017-01-25
10812269022047Torque Limiter Ball HandleMIAMI DEVICE SOLUTIONS LLCMDS000604AOT2017-06-26
10812269025796Torque Limiter Ball HandleMIAMI DEVICE SOLUTIONS LLCMDS000608AOT2018-12-17
10885380086489CARDINAL HEALTHCardinal Health 200, LLCCH10-00502018-06-05
10885380086496CARDINAL HEALTHCardinal Health 200, LLCCH10-00492018-06-05
10886982129857NASynthes GmbH05.001.2152016-12-31
10886982129871NASynthes GmbH05.001.2162016-12-31
10886982237743NASynthes GmbH511.7702016-12-31
10886982237774NASynthes GmbH511.7712016-12-31
10886982237804NASynthes GmbH511.7732016-12-31
10886982237835NASynthes GmbH511.7742016-12-31
10886982237866NASynthes GmbH511.7762016-12-31
10886982237897NASynthes GmbH511.7772016-12-31
10886982257758NASynthes GmbH03.140.0232018-07-18
10886982261144NASynthes GmbH03.312.8512017-04-19
10886982336194NASynthes GmbH03.527.1202024-10-09
10886982336378NASynthes GmbH03.535.2502024-10-09
03662663093255LineSiderHighridge Medical, LLCCMP-020772025-10-03
07613327648317PANGEAStryker GmbH5421622026-02-04
00199150020591Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X06220122025-06-30
08800071017073SignexOSTEONIC CO.,Ltd.Y7D.150102025-06-27
08800071017080SignexOSTEONIC CO.,Ltd.Y7Z.400102025-06-27
08809539697451Surgical InstrumentOSTEONIC CO.,Ltd.Y1Z.350302025-06-27
00763000993276Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X54851472025-04-27
07640172552872icotec Systems, Torque-Limiting Adapter, 3.5 Nmicotec AG60-0352025-03-05
04026575177127MobileLink Acetabular Cup System - InstrumentsWALDEMAR LINK GmbH & Co. KG183-167/012022-12-16
04026575187843MobileLink Acetabular Cup System - InstrumentsWALDEMAR LINK GmbH & Co. KG183-167/022022-12-16
00810149981234ROOTTTRATE LLCTW502024-11-21
07612334236487NASynthes GmbH03.527.1202024-10-09
07612334236722NASynthes GmbH03.535.2502024-10-09
07290115932645VersaLink Torque LimiterPREMIA SPINE LTD872062024-10-01
07290115934151Torque LimiterPREMIA SPINE LTD858362024-10-01
07290115935554Versalink Torque LimiterPREMIA SPINE LTD872052024-10-01
09120034300707Screwdriver ShankI.T.S. GmbH54353-90SH2018-10-23
09120034300714Screwdriver ShankI.T.S. GmbH54353-230SH2018-10-23
09120034304439Screwdriver ShankI.T.S. GmbH54502-1202018-10-24
09120034306440Hexagon-ShankI.T.S. GmbHKM 48-3482018-11-13
09120047295977Screwdriver ShankI.T.S. GmbH54253-90SH2018-10-24
09120047298893Torque ShankI.T.S. GmbH54095-1002018-10-25
09120047299517Hexagon ShankI.T.S. GmbH54253-1002018-10-25
09120047300282Torque ShankI.T.S. GmbH54096-1002018-11-14
09120047301081Torque ShankI.T.S. GmbH54097-802018-10-24
09120047301098Torque ShankI.T.S. GmbH54098-802018-10-24
09120047301104Hexagon ShankI.T.S. GmbH54099-1002018-10-24
09120047301111Hexagon ShankI.T.S. GmbH54100-1002018-10-24
09120047305478Torque ShankI.T.S. GmbH54101-802018-10-25
09120047306239Hexagon ShankI.T.S. GmbH54253-3002018-10-23
07290115934465Screwdriver with Torque Limiter (Torx)PREMIA SPINE LTD865672024-09-03
08800089403837Surgical InstrumentJeil Medical Corporation111-TD-0402024-08-28
08806390862400Surgical InstrumentJeil Medical Corporation111-TD-0202018-11-28
08809265158424Surgical InstrumentJeil Medical Corporation111-TD-0102018-11-28
07290117350980CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDTorque Limiter 0.8Nm2024-06-05
07290117350997CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDTorque Limiter 2.5Nm2024-06-05
00885556860274Surgical InstrumentsSmith & Nephew, Inc.G2071532022-12-22
00885556863442Titan Modular Shoulder System 2.5Smith & Nephew, Inc.TRQ-0920-086-012022-12-21
07613327505337PANGEAStryker GmbH7064202023-06-13
07290117350751CarboClear X Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDVariable Torque Limiter2023-04-18
M269G2071531Integra®Ascension Orthopedics, Inc.G2071532017-08-30
07640187461466Power Tool TL Attachment 3.5mmBonebridge AGB-4200022022-12-23
04048844281052MUTARS® torque wrench M8 M10implantcast GmbH775512302022-08-26
10885862028891NAExactech, Inc.151-00-092022-07-28
10885862056191NAExactech, Inc.209-30-002022-07-28
00888867225091Arthrex®ARTHREX, INC.AR-9545-T15H2022-07-15
B06217500026Pisces-SAOsseus Fusion Systems, LLC1750-00262022-05-24
07611819655577NASynthes GmbH03.140.0232018-07-18
07612334107640NASynthes GmbH03.312.8512017-04-19