FDA.reportPublic FDA data

Spinal guidewire

Definition
A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.
GUDID devices
279
Last updated
2026-10-04 01:41:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613327096200ES2 SPINAL SYSTEMStryker Corporation482802322019-12-16
07613327119299XIA PRECISIONStryker Corporation482370052018-09-24
07613327263213XIA IIStryker Corporation480402302019-12-16
07613327265026XIA PRECISIONStryker Corporation482302302019-12-16
07613327265125XIA PRECISIONStryker Corporation482302352019-12-16
07613327265286XIA PRECISIONStryker Corporation482302312018-09-24
07613327266450ES2 SPINAL SYSTEMStryker Corporation482802332019-12-16
07613327271959ARIAStryker Corporation487550072019-12-16
07613327275834RADIUSStryker Corporation4866190452019-12-16
07613327275841RADIUSStryker Corporation4866190462019-12-16
07613327343434LITeStryker CorporationFC-128-22-B-22019-12-13
07613327343441LITeStryker CorporationFC-110-22-B-22019-12-13
07613327343458LITeStryker CorporationFC-150-22-B-42019-12-13
07613327343489LITeStryker CorporationFC-128-22-B-42019-12-13
07613327343519LITeStryker CorporationFC-145-22-C-42019-12-13
07613327343526LITeStryker CorporationFC-140-22-B-22019-12-13
07613327343533LITeStryker CorporationFC-145-22-C-22019-12-13
07613327343540LITeStryker CorporationFC-150-22-B-22019-12-13
07613327343557LITeStryker CorporationFC-110-22-B-42019-12-13
07613327343564LITeStryker CorporationFC-140-22-B-42019-12-13
10888857001022SERENGETI MI Retractor SystemVB Spine LLC1001-901222022-08-05
10888857018143CASPIAN® Spinal SystemVB Spine LLC1111-G016102015-09-30
10888857035461RAVINE® Lateral Access SystemVB Spine LLC2701-900632022-02-14
10888857083837NILE™ Spinal SystemVB Spine LLC3711-G106102015-09-24
10888857083844NILE™ Spinal SystemVB Spine LLC3711-G136102015-09-30
10888857104228EVEREST Spinal SystemVB Spine LLC5101-900452022-08-09
10888857104235EVEREST Spinal SystemVB Spine LLC5101-900462022-08-09
10888857104280EVEREST Spinal SystemVB Spine LLC5101-900512022-08-09
10888857104341EVEREST Spinal SystemVB Spine LLC5101-900572022-08-09
10888857104358EVEREST Spinal SystemVB Spine LLC5101-900582022-08-09
10888857157729EVEREST Spinal SystemVB Spine LLC5101-901002022-08-09
10888857216570EVEREST Spinal SystemVB Spine LLC5101-901492022-08-09
10888857243910RAVINE® Lateral Access SystemVB Spine LLCK2-27-2056-012022-02-14
10888857405455EVEREST Spinal SystemVB Spine LLC5101-90100-G12022-08-09
10888857405462EVEREST Spinal SystemVB Spine LLC5101-90101-G12022-08-09
10888857463271NIAGARA® Lateral Access SystemVB Spine LLCAC01-90064-G42020-06-10
10888857596627TERRA NOVA® MI Access SystemVB Spine LLC1501-900602025-11-24
10888857596955EVEREST® Spinal SystemVB Spine LLCPRO-14282026-03-03
20705034764051NASynthes GmbH292.0202019-08-29
00841732150614GENERIC Surgical InstrumentsCTL Medical Corporation50-1000-0042023-09-15
00841732163782GENERIC Surgical InstrumentsCTL Medical Corporation50-1000-0012023-09-15
00643169402409n/aMEDTRONIC SOFAMOR DANEK, INC.90100005052025-10-16
00643169402423n/aMEDTRONIC SOFAMOR DANEK, INC.90100005152025-10-16
00810152100813DYNAMIS™ Implant SystemPROMETHEAN RESTORATIVE LLCSI00562025-11-10
00810152100820DYNAMIS™ Implant SystemPROMETHEAN RESTORATIVE LLCSI00572025-11-10
00810152100837DYNAMIS™ Implant SystemPROMETHEAN RESTORATIVE LLCSI00582025-11-10
00840180543467General InstrumentsALPHATEC SPINE, INC.CI-11914-27-22025-10-17
00840180543504General InstrumentsALPHATEC SPINE, INC.CI-11914-30-22025-10-17
00840311245536Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.04-GWCAP2026-03-18
00840311245543Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.04-GWTUBE2026-03-18
00840311246755Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-GW-500-BLUNT2026-04-30
00840311246762Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-GW-500-BLUNT-SS2026-04-30
00840311246779Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-GW-500-BLUNT-TH2026-04-30
00840311246786Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-GW-500-SHARP2026-04-30
00840311246793Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-GW-500-SHARP-SS2026-04-30
00840311246809Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-GW-500-SHARP-TH2026-04-30
00840311246816Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-GW-550-BLUNT2026-04-30
00840311246830Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.51-K-WIRE2026-03-18
00850014575779Lumbar Interbody Fusion System (OLLIF)ADVANCED RESEARCH MEDICAL LLC01-9080-18U2022-08-12
03662663127660PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLC1001-18-022025-11-12
03662663273428Timberline Lateral Fusion SystemHighridge Medical, LLC8734-10012025-11-07
03662663273442Timberline Lateral Fusion SystemHighridge Medical, LLC8734-10032025-11-07
05414734400022NAST. JUDE MEDICAL, INC.11022015-03-19
07290014381179K-Wire, Blunt Sharp Tip, L=352, Ø1.7mm XL Shidi-TecPREMIA SPINE LTD872842024-09-05
07290115934946K-Wire, CoCr, Blunt Sharp Tip, L=457, Ø1.7mm XL DKWAPREMIA SPINE LTD874462024-09-05
03662663092876LineSiderHighridge Medical, LLCCMP-018232025-10-03
03662663086271LineSiderHighridge Medical, LLCASY-002122025-10-03
03662663087834LineSiderHighridge Medical, LLCASY-004622025-10-03
03662663093262LineSiderHighridge Medical, LLCCMP-020782025-10-03
03662663093378LineSiderHighridge Medical, LLCCMP-021532025-10-03
03662663093385LineSiderHighridge Medical, LLCCMP-021542025-10-03
03662663093392LineSiderHighridge Medical, LLCCMP-021552025-10-03
03662663093408LineSiderHighridge Medical, LLCCMP-021562025-10-03
03662663093453LineSiderHighridge Medical, LLCCMP-023572025-10-03
03662663093712LineSiderHighridge Medical, LLCCMP-026232025-10-03
03662663093729LineSiderHighridge Medical, LLCCMP-026242025-10-03
03662663093736LineSiderHighridge Medical, LLCCMP-026252025-10-03
03662663093743LineSiderHighridge Medical, LLCCMP-026262025-10-03
03662663093750LineSiderHighridge Medical, LLCCMP-026272025-10-03
03662663095907FlareHawkHighridge Medical, LLCFHTPKW12025-10-03