FDA.reportPublic FDA data

Internal spinal fixation system cable tensioner

Definition
A manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device.
GUDID devices
59
Last updated
2026-07-28 06:05:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.55990152026-07-18
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.55961142026-07-17
00190376706450InvictusALPHATEC SPINE, INC.178472026-04-09
03607505503264JAZZ LOCKIMPLANETCrimper2017-05-18
03607505503271JAZZ LOCKIMPLANETTensioner Stem -JLA2017-05-18
03607505503417JAZZ SystemIMPLANETStraight Passer – 15mm2017-10-13
03607505503424JAZZ SystemIMPLANETStraight Passer – 20mm2017-10-13
03607505503431JAZZ SystemIMPLANETStraight Passer – 25mm2017-10-13
03607505503448JAZZ SystemIMPLANETRound Passer2017-10-13
03607505503455JAZZ SystemIMPLANETRound Passer – Angled2017-10-13
03607505503479JAZZ SystemIMPLANETUniversal 120° Stem Short2017-10-13
03662663109857Dynesys Dynamic Stabilization SystemHighridge Medical, LLC07.01297.0012026-01-12
03662663109864Dynesys Dynamic Stabilization SystemHighridge Medical, LLC07.01298.0012026-01-12
10705034769127NASynthes GmbH321.7442016-12-31
03662663161411The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H30022025-12-15
03662663161473The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H60022025-12-15
03662663161480The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H60032025-12-15
03662663161497The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H60052025-12-15
03662663161503The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H60062025-12-15
03662663192606The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H60012025-12-15
00763000675035TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.82390002024-11-04
00840298704620Songer® Spinal Cable SystemPioneer Surgical Technology, Inc.400-1202024-08-23
00763000021382Medtronic Resuable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X06170252022-11-13
00763000233846Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X11180432022-10-07
07611819746190NASynthes GmbH321.7442016-12-31
00673978047690ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.825-2102021-12-19
00763000108403TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.82390002021-07-03
03607505504070JAZZ SystemIMPLANETTensioner Gen.II -Stem 3.5-4mm2021-05-05
10889981257583JAZZ SystemIMPLANETTensioner Gen.II -Stem 3,5-4mm2021-02-23
10889981220914Mariner CapSeaspine Orthopedics Corporation5690622020-11-24
10889981220938Mariner CapSeaspine Orthopedics Corporation5692952020-11-24
10889981220945Mariner CapSeaspine Orthopedics Corporation5693262020-11-24
00846468074685Zimmer® Cable-Ready® SystemPioneer Surgical Technology, Inc.00-2232-060-012020-09-25
00846468074692Zimmer® Cable-Ready® SystemPioneer Surgical Technology, Inc.00-2232-060-182020-09-25
00846468074708Zimmer®* Cable-Ready®* SystemPioneer Surgical Technology, Inc.00-2232-060-192020-09-25
00846468074715Zimmer®* Cable-Ready®* SystemPioneer Surgical Technology, Inc.00-2232-060-202020-09-25
00846468074722Zimmer®* Cable-Ready®* SystemPioneer Surgical Technology, Inc.00-2232-060-212020-09-25
00846468074739Zimmer®* Cable-Ready®* SystemPioneer Surgical Technology, Inc.00-2232-060-222020-09-25
10889981188351JAZZ SystemIMPLANETTensioner Generation II2020-09-14
10889981188368JAZZ SystemIMPLANET120 Degree Stem2020-09-14
10889981188405JAZZ SystemIMPLANETUniversal Stem 90 Degree2020-09-14
10889981188412JAZZ SystemIMPLANETUniversal 120 Degree Stem2020-09-14
10889981188429JAZZ LockIMPLANETCrimper2020-09-14
10889981188436JAZZ LockIMPLANETJAZZ Lock Tensioner Stem2020-09-14
03607505502984JAZZ SystemIMPLANETTensioner Gen. II - 90° Stem2015-09-24
03607505502991JAZZ SystemIMPLANETTensioner Gen. II - 120° Stem2015-09-24
03607505503004JAZZ SystemIMPLANETTensioner Gen. II - 135° Stem2015-09-24
03607505503127JAZZ SystemIMPLANETTensioner Gen. II - 90° Low Profile Stem2015-09-24
03607505503134JAZZ SystemIMPLANETTensioner Gen. II - 120° Low Profile Stem2015-09-24
03607505503141JAZZ SystemIMPLANETTensioner Gen. II - 135° Low Profile Stem2015-09-24
03607505503165JAZZ SystemIMPLANETTensioner Gen. II - Universal 90° Stem2015-09-24
03607505503172JAZZ SystemIMPLANETTensioner Gen. II - Universal 120° Stem2015-09-24
03607505503189JAZZ SystemIMPLANETTensioner Gen. II - Universal 135° Stem2015-09-24
03607505512952JAZZ SystemIMPLANETTensioner Gen. II - Ratchet2015-09-24
03607505512969JAZZ SystemIMPLANETTensioner Gen. II – Mobile Capstan2015-09-24
03607505512976JAZZ SystemIMPLANETTensioner Gen. II - Winch2015-09-24
03607505500560JAZZ SystemIMPLANETTensioner2015-09-24
03607505502953JAZZ SystemIMPLANETTensioner Gen. II2015-09-24
00643169726932TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.82390002018-03-31