FDA.reportPublic FDA data

Orthopaedic guidewire, single-use

Definition
A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) 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
156
Last updated
2024-09-06 08:47:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B26710230050Flow-Screw™Flow-FX102-30-052024-08-29
05397283000717Pro-X1X-BOLT ORTHOPEDICS INC.XBT0249002024-08-27
M6950010000400Headless Screw System InstrumentsTyber Medical, LLC001-000042019-12-19
00888867338272Arthrex®ARTHREX, INC.ABS-4090D2024-07-23
M6950010000020Headless Screw System InstrumentsTyber Medical, LLC001-0000022019-12-19
M6950010000060Headless Screw System InstrumentsTyber Medical, LLC001-0000062019-12-19
M695HTR040091020Orion Headed Screw System InstrumentsTyber Medical, LLCHTR-04-0091022019-12-19
M695HTR040091040Orion Headed Screw System InstrumentsTyber Medical, LLCHTR-04-0091042019-12-19
M695HTR040092030Orion Headed Screw System InstrumentsTyber Medical, LLCHTR-04-0092032019-12-19
M695HTR040092060Orion Headed Screw System InstrumentsTyber Medical, LLCHTR-04-0092062019-12-19
00843511123307Omnia Medical PsiFOMNIA MEDICAL, LLC11-14-S180-BT2024-06-12
00843511123314Omnia Medical PsiFOMNIA MEDICAL, LLC11-14-S200-BT2024-06-12
00843511123321Omnia Medical PsiFOMNIA MEDICAL, LLC11-14-S230-BT2024-06-12
00843511123338Omnia Medical PsiFOMNIA MEDICAL, LLC11-14-S300-BT2024-06-12
00840118121774Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONDG28402024-06-01
00840118125024Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIS 4082024-06-01
00840118125031Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIS 2402024-06-01
00840118125055Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIS 2812024-06-01
00840118125062Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIS 4062024-06-01
00840118125079Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIS 2252024-06-01
00840118125086Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIS 200-S2024-06-01
00840118125093Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIS 100-S2024-06-01
00840118125109Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIM 4102024-06-01
00840118125116Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIM 2422024-06-01
00840118125154Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIM 4122024-06-01
00840118125161Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIM 4142024-06-01
00840118125178Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONFIM 4162024-06-01
00810136432718OptimalHT™Forma Medical, Inc.6100.22092024-05-23
50810136432720OptimalHT™Forma Medical, Inc.6100.22112024-05-23
50810136432737OptimalHT™Forma Medical, Inc.6100.27092024-05-23
50810136432744OptimalHT™Forma Medical, Inc.6100.27112024-05-23
10845854044322CONMEDConmed CorporationC-GS24P2017-09-07
50810136430894OptimalHT™Forma Medical, Inc.6100.26092024-03-09
50810136430900OptimalHT™Forma Medical, Inc.6100.26112024-03-09
07613327614435PANGEAStryker GmbH5420362024-03-01
00841731129598ALPHALOK Plating SystemVILEX LLCK60-18T2024-02-21
00841731147554ALPHALOK Plating SystemVILEX LLCK60-18S2024-02-21
00840194466974Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-50802024-02-14
00889795132680Precision MIS Bunion SystemPARAGON 28, INC.P27-192-20102024-01-24
00889795132697Precision MIS Bunion SystemPARAGON 28, INC.P27-192-30232024-01-24
00889795132703Precision MIS Bunion SystemParagon 28, Inc.P27-192-35232024-01-24
00889795132710Precision MIS Bunion SystemParagon 28, Inc.P27-192-40232024-01-24
00889795132840Precision MIS Bunion SystemParagon 28, Inc.P27-182-00012024-01-24
00889795132857Precision MIS Bunion SystemParagon 28, Inc.P27-999-30CW2024-01-24
00196449010141A.L.P.S. mvX™Tyber Medical, LLC7700181602024-01-20
00196449010158A.L.P.S. mvX™Tyber Medical, LLC7700180902024-01-20
00196449016402A.L.P.S. mvX™Tyber Medical, LLC7709001032024-01-20
00840194465311Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-11102024-01-16
00840194465328Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-10102024-01-16
00840194465335Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-21122024-01-16
00840194465342Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-20122024-01-16
00840194465359Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-31152024-01-16
00840194465366Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-30152024-01-16
00840194465373Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-41072024-01-16
00840194465380Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-40072024-01-16
00840194465397Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-41102024-01-16
00840194465403Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-40102024-01-16
00840194465410Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-41152024-01-16
00840194465427Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-40152024-01-16
00840194465434Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-41202024-01-16
00840194465441Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-40202024-01-16
00840194465458Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-41232024-01-16
00840194465465Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-40232024-01-16
00840194465472Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-51072024-01-16
00840194465489Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-50072024-01-16
00840194465496Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-51102024-01-16
00840194465502Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-50102024-01-16
00840194465519Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-51152024-01-16
00840194465526Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-50152024-01-16
00840194465533Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-51232024-01-16
00840194465540Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-50232024-01-16
00840194465557Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-51452024-01-16
00840194465564Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-50802024-01-16
00840194465571Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-61072024-01-16
00840194465588Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-60072024-01-16
00840194465595Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-61102024-01-16
00840194465601Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-60102024-01-16
00840194465618Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-61152024-01-16
00840194465625Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-60152024-01-16
00840194465632Stainless Steel Guide WiresORTHOPEDIATRICS CORP.01-9473-61202024-01-16