FDA.reportPublic FDA data

Orthopaedic guidewire, single-use

Definition
A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.
GUDID devices
303
Last updated
2026-10-06 03:49:46

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10886982357335VOLTSynthes GmbH03.542.0602026-09-25
10886982357342VOLTSynthes GmbH03.542.0612026-09-25
10886982357359VOLTSynthes GmbH03.542.0622026-09-25
10886982357366VOLTSynthes GmbH03.542.0632026-09-25
10886982357373VOLTSynthes GmbH03.542.0642026-09-25
10886982357380VOLTSynthes GmbH03.542.0652026-09-25
10886982357397VOLTSynthes GmbH03.542.0662026-09-25
10886982357403VOLTSynthes GmbH03.542.0702026-09-25
10886982357410VOLTSynthes GmbH03.542.0712026-09-25
10886982357427VOLTSynthes GmbH03.542.0722026-09-25
10886982357434VOLTSynthes GmbH03.542.0732026-09-25
10886982357441VOLTSynthes GmbH03.542.0742026-09-25
10886982357458VOLTSynthes GmbH03.542.0752026-09-25
10886982357465VOLTSynthes GmbH03.542.0762026-09-25
10886982357472VOLTSynthes GmbH03.542.0772026-09-25
10886982357489VOLTSynthes GmbH03.542.0782026-09-25
10886982357823VOLTSynthes GmbH03.542.0202026-09-25
10886982357830VOLTSynthes GmbH03.542.0212026-09-25
00885556830413Surgical InstrumentsSmith & Nephew, Inc.WIRE-0930-501S2022-12-22
00885556830420Surgical InstrumentsSmith & Nephew, Inc.WIRE-0930-501T2022-12-22
00885556865316Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.2681142023-01-19
00889795097972Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-955-15502020-12-15
008401944958993P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-10052026-06-10
008401944959053P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-10102026-06-10
008401944959123P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-10152026-06-10
008401944959293P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-10202026-06-10
008401944959363P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-20052026-06-10
008401944959433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-20102026-06-10
008401944959503P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-20152026-06-10
008401944959673P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-20202026-06-10
008401944961483P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-10052026-06-10
008401944961553P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-10102026-06-10
008401944961623P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-10152026-06-10
008401944961793P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-10202026-06-10
008401944961863P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-20052026-06-10
008401944961933P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-20102026-06-10
008401944962093P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-20152026-06-10
008401944962163P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-20202026-06-10
008401944964143P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-10052026-06-10
008401944964213P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-10102026-06-10
008401944964383P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-10152026-06-10
008401944964453P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-10202026-06-10
008401944964523P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-20052026-06-10
008401944964693P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-20102026-06-10
008401944964763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-20152026-06-10
008401944964833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-20202026-06-10
008401944966813P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-10052026-06-10
008401944966983P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-10102026-06-10
008401944967043P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-10152026-06-10
008401944967113P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-10202026-06-10
008401944967283P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-20052026-06-10
008401944967353P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-20102026-06-10
008401944967423P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-20152026-06-10
008401944967593P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-20202026-06-10
008100743050372.7x250mm Transsacral Beveled Tip Wire THDOsteocentric Technologies, Inc.2004-01412025-10-21
008100743050442.7x350mm Transsacral Beveled Tip Wire THDOsteocentric Technologies, Inc.2004-01422025-10-21
008100743050512.7x450mm Transsacral Beveled Tip Wire THDOsteocentric Technologies, Inc.2004-01432025-10-21
00810136430158OptimalHT™Forma Medical, Inc.6100.20092023-12-22
00810136430165OptimalHT™Forma Medical, Inc.6100.20112023-12-22
00810136430172OptimalHT™Forma Medical, Inc.6100.21092023-12-22
00810136430189OptimalHT™Forma Medical, Inc.6100.21112023-12-20
00810136430363OptimalHT™Forma Medical, Inc.6100.20142023-12-20
00810136430370OptimalHT™Forma Medical, Inc.6100.21142023-12-20
00810136430899OptimalHT™Forma Medical, Inc.6100.26092024-03-09
00810136430905OptimalHT™Forma Medical, Inc.6100.26112024-03-09
00810136432725OptimalHT™Forma Medical, Inc.6100.22112024-05-23
00810136432732OptimalHT™Forma Medical, Inc.6100.27092024-05-23
00810136432749OptimalHT™Forma Medical, Inc.6100.27112024-05-23
00840124516496FibFixFUSION ORTHOPEDICS, LLCCD-FN-02162026-04-09
00840124516502FibFixFUSION ORTHOPEDICS, LLCCD-FN-03162026-04-09
00840124517509FibFixFUSION ORTHOPEDICS, LLCCD-FN-0216-S2026-04-09
00840124517516FibFixFUSION ORTHOPEDICS, LLCCD-FN-0316-S2026-04-09
00840124518551FibFixFUSION ORTHOPEDICS, LLCCD-FX-03112026-04-09
00840124521407MetalogixFUSION ORTHOPEDICS, LLC9003172025-09-30
00840124521414MetalogixFUSION ORTHOPEDICS, LLC9003202025-09-30
00840124521766MetalogixFUSION ORTHOPEDICS, LLCCD-MX-00042025-09-30
00840124524712FuzeFix Max FTFUSION ORTHOPEDICS, LLCCD-CS-0950-S2025-11-03
00841731135315Redemption VILEX LLCRD-K400-322026-01-12
00841731135513Redemption VILEX LLCRD-K650-242026-01-12
00841731135568TITANEX VILEX LLCK150-16SC2026-05-15