FDA.reportPublic FDA data

Orthopaedic counter-torque/rod-pushing instrument

Definition
A hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.
GUDID devices
1,094
Last updated
2026-10-20 10:18:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00824846010722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X07260022026-10-09
07613327006902ES2 SPINAL SYSTEMStryker Corporation482800802019-11-08
07613327114805XIA 4.5 EVOLUTIONStryker Corporation481380262019-11-08
07613327132687XIA 4.5 System - XIA CTStryker Corporation488560072016-01-18
07613327135411LITe PEDICLE BASED RETRACTORStryker Corporation487607612019-11-08
07613327262278XIAStryker Corporation038070262019-11-08
07613327262810DIAPASONStryker Corporation480270002019-11-08
07613327262834THOR Anterior Plating SystemStryker Corporation480315002018-09-24
07613327265453XIA 3Stryker Corporation482370262019-11-08
07613327266955MANTIS ReduxStryker Corporation482894802018-09-24
07613327271720OASYSStryker Corporation485620352019-11-08
07613327273335TRIOStryker Corporation489060802019-11-08
07613327273342TRIOStryker Corporation489060812019-11-08
07613327276374RADIUSStryker Corporation4866192352019-11-08
10888857017849CASPIAN® Spinal SystemVB Spine LLC1101-902772021-04-06
10888857030572PYRENEES® Cervical Plate SystemVB Spine LLC201-902502021-04-02
10888857053076MESA Small Stature Spinal SystemVB Spine LLC3001-901032022-08-06
10888857143173MESA Spinal SystemVB Spine LLC801-900542022-08-05
10888857143302MESA® Spinal SystemVB Spine LLC801-900692021-04-05
10888857143333MESA Spinal SystemVB Spine LLC801-900732022-08-05
10888857210127EVEREST Spinal SystemVB Spine LLC5101-901272022-08-09
10888857241930PYRENEES® Cervical Plate SystemVB Spine LLCK2-02-2304-012021-04-02
10888857261532PYRENEES® Cervical Plate SystemVB Spine LLC6808-900032016-05-10
10888857577749Vulcan™ Spinal SystemVB Spine LLC8042-902412025-12-19
04054896000985Torque LimiterSilony Medical GmbHVI-14502026-09-18
04054896022291Torque LimiterSilony Medical GmbHVI-18002026-09-18
04054896024691Torque LimiterSilony Medical GmbHVI-41602026-09-18
04054896049137Torque LimiterSilony Medical GmbHVI-18502026-09-18
04054896052694Torque LimiterSilony Medical GmbHVI-18602026-09-18
04054896079479Torque LimiterSilony Medical GmbHVI-50412026-09-18
04054896079912Torque LimiterSilony Medical GmbHVI-04502026-09-18
04054896080093Torque LimiterSilony Medical GmbHVI-07612026-09-18
04054896080116Torque LimiterSilony Medical GmbHVI-08202026-09-18
04054896083131Torque LimiterSilony Medical GmbHVI-44502026-09-18
00840314269638gSourceGSOURCE LLCgS 82.80352024-10-15
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-17002026-08-18
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.33044-0002026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.33045-0002026-07-31
00840606191999Overwatch PCFSPINAL ELEMENTS, INC.33051-0002026-07-31
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.593250152026-07-17
00763000837181Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.55990112026-07-17
00199150002139N/AMEDTRONIC SOFAMOR DANEK, INC.593250132026-07-16
00199150002146N/AMEDTRONIC SOFAMOR DANEK, INC.593250162026-07-16
00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.593250042026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.593250052026-07-16
08809885799816AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.GS110-19502025-03-17
08800104097966Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-29002025-03-17
08800104099878Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-17102025-03-17
08809885799762Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-19002025-03-17
00841732164123GENERIC Surgical InstrumentsCTL Medical Corporation50-4000-0062023-09-14
00841732164130TAURUS Pedicle Screw SystemCTL Medical Corporation50-4000-0072023-09-14
00841732164208TAURUS Pedicle Screw SystemCTL Medical Corporation50-6000-0032023-09-14
00841732164284GENERIC Surgical InstrumentsCTL Medical Corporation50-7000-0052023-09-15
03701313009526KHEIRONS.M.A.I.O01PR20302026-07-06
03701313009519KHEIRONS.M.A.I.O01PR20202026-07-05
M711LS7490Vector™ Pedicle Screw SystemINNO Holdings, Inc.LS-7492026-06-05
10705034647814TRIALTISMedos International Sàrl5161-00-51442026-06-03
00841732122710GENERIC Surgical InstrumentsCTL Medical Corporation119.70652019-10-18
00841732124172PICASSO II MIS Spinal SystemCTL Medical Corporation119.70682019-10-18
00841732141100GENERIC Surgical InstrumentsCTL Medical Corporation119.70642023-09-15
00190376061863ArsenalALPHATEC SPINE, INC.871312020-06-17
00190376147918InvictusALPHATEC SPINE, INC.161482020-06-17
00190376149318InvictusALPHATEC SPINE, INC.160302020-06-17
00190376149325InvictusALPHATEC SPINE, INC.16058-012020-06-17
00190376149332InvictusALPHATEC SPINE, INC.16058-022020-06-17
00190376149349InvictusALPHATEC SPINE, INC.16058-032020-06-17
00190376192826InvictusALPHATEC SPINE, INC.170462020-06-17
00190376195728InvictusALPHATEC SPINE, INC.170252020-06-17
00190376204574InvictusALPHATEC SPINE, INC.170472020-06-17
00190376204673InvictusALPHATEC SPINE, INC.171462020-06-17
00190376218229InvictusALPHATEC SPINE, INC.170572020-06-17
00190376218663InvictusALPHATEC SPINE, INC.170492020-06-17
00197157077884ZAVATION COUNTER TORQUE Zavation LLC989-11472026-05-12
00197157077891ZAVATION COUNTER TORQUE Zavation LLC989-20682026-05-12
00197157077907ZAVATION COUNTER TORQUE Zavation LLC989-21682026-05-12
00197157081331ZAVATION CUSTOMZavation LLCZAV-14082026-05-08
00199150024902n/aMEDTRONIC SOFAMOR DANEK, INC.36501172026-03-27
00199150051182Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X08250022025-10-31
00810141040502Foundation Surgical InterwedgeFOUNDATION SURGICAL GROUP INCFS50-3300002025-10-24
00811801031670ArsenalALPHATEC SPINE, INC.CI-100272020-09-19