FDA.reportPublic FDA data

External orthopaedic fixation system, single-use

Definition
An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.
GUDID devices
2,722
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00885556013182Jet-XSmith & Nephew, Inc.71066559S2015-08-30
00885556013496Jet-XSmith & Nephew, Inc.71065504S2015-08-30
00885556013540Jet-XSmith & Nephew, Inc.71065559S2015-08-30
00885556013663Jet-XSmith & Nephew, Inc.71065309S2015-08-30
00885556051597ILIZAROV SYSTEMSSmith & Nephew, Inc.719303332015-08-29
00885556119389TAYLOR SPATIAL FRAMESmith & Nephew, Inc.710702852015-08-29
00885556119396TAYLOR SPATIAL FRAMESmith & Nephew, Inc.710702842015-08-29
00885556119648Jet-XSmith & Nephew, Inc.71065454S2015-08-30
00885556119655Jet-XSmith & Nephew, Inc.71065354S2015-08-30
00885556158739TAYLOR SPATIAL FRAMESmith & Nephew, Inc.710702922015-08-29
00885556158746TAYLOR SPATIAL FRAMESmith & Nephew, Inc.710702912015-08-29
00885556746073SMART TSFSmith & Nephew, Inc.710785502021-08-10
00885556746134SMART TSFSmith & Nephew, Inc.710752952023-03-29
00889797102940NAWRIGHT MEDICAL TECHNOLOGY, INC.EF0025002022-06-23
00889797103015NAWRIGHT MEDICAL TECHNOLOGY, INC.EF3005PK2022-06-23
00889797103022NAWRIGHT MEDICAL TECHNOLOGY, INC.EF3010PK2022-06-23
03596010029614ILIZAROVSmith & Nephew, Inc.1005912017-11-13
03596010029645ILIZAROVSmith & Nephew, Inc.1006132015-08-29
03596010029652ILIZAROVSmith & Nephew, Inc.1006142015-08-29
03596010029669ILIZAROVSmith & Nephew, Inc.1006152015-08-29
03596010029676ILIZAROVSmith & Nephew, Inc.1006162015-08-29
03596010029690ILIZAROVSmith & Nephew, Inc.1006942017-11-13
03596010031143ILIZAROVSmith & Nephew, Inc.1020702017-11-13
03596010031150ILIZAROVSmith & Nephew, Inc.1020722017-11-13
03596010031167ILIZAROVSmith & Nephew, Inc.1020802017-11-13
03596010031174ILIZAROVSmith & Nephew, Inc.1020822017-11-13
03596010031341ILIZAROVSmith & Nephew, Inc.1022752017-11-13
03596010031358ILIZAROVSmith & Nephew, Inc.1022782017-11-13
03596010031365ILIZAROVSmith & Nephew, Inc.1022812017-11-13
03596010031372ILIZAROVSmith & Nephew, Inc.1022842017-11-13
03596010031389ILIZAROVSmith & Nephew, Inc.1022872017-11-13
03596010031396ILIZAROVSmith & Nephew, Inc.1022902017-11-13
03596010031402ILIZAROVSmith & Nephew, Inc.1022932017-11-13
03596010031600ILIZAROVSmith & Nephew, Inc.1024122017-11-13
03596010031617ILIZAROVSmith & Nephew, Inc.1024152017-11-13
03596010031747ILIZAROVSmith & Nephew, Inc.1027152017-11-13
03596010031754ILIZAROVSmith & Nephew, Inc.1027182017-11-13
03596010031761ILIZAROVSmith & Nephew, Inc.1027212017-11-13
03596010101150ILIZAROVSmith & Nephew, Inc.2019002015-09-28
03596010170613ILIZAROVSmith & Nephew, Inc.710120002017-11-13
03596010170637OTHER EXTERNAL FIXATIONSmith & Nephew, Inc.710120102015-08-29
03596010413918ILIZAROV SYSTEMSSmith & Nephew, Inc.L1001122015-08-29
03596010426628ILIZAROV SYSTEMSSmith & Nephew, Inc.L1001102015-08-29
03596010426635ILIZAROV SYSTEMSSmith & Nephew, Inc.L1001112015-08-29
03596010475749OTHER EXTERNAL FIXATIONSmith & Nephew, Inc.710610022015-08-29
03596010475756OTHER EXTERNAL FIXATIONSmith & Nephew, Inc.710610032015-08-29
03596010475763OTHER EXTERNAL FIXATIONSmith & Nephew, Inc.710610052015-08-29
03596010486776Jet-XSmith & Nephew, Inc.710630022015-08-29
08033201840795ILIZAROV SYSTEMSMEDICALPLASTIC SRL1001102016-10-07
08033201840801ILIZAROV SYSTEMSMEDICALPLASTIC SRL1001112016-10-07
08033201840818ILIZAROV SYSTEMSMEDICALPLASTIC SRL1001122016-10-07
08033201840993ILIZAROV SYSTEMSMEDICALPLASTIC SRL1006002016-09-30
08033201841006ILIZAROV SYSTEMSMEDICALPLASTIC SRL1006012016-09-30
08033201841013ILIZAROV SYSTEMSMEDICALPLASTIC SRL1007002016-09-30
08033201842324ILIZAROV SYSTEMSMEDICALPLASTIC SRL710130002016-09-30
08033201842331ILIZAROV SYSTEMSMEDICALPLASTIC SRL710130022016-09-30
18052469476406ORTHOFIX MODULSYSTEMORTHOFIX SRL12022-12-27
10886982346889MAXFRAMESynthes GmbH03.314.1002025-04-23
08059386747391DOLPHIXCITIEFFE SRLSS bone screw ø5mm L160-40mm2025-04-02
08059386747407DOLPHIXCITIEFFE SRLClamp with SS bone screw ø5mm L160-40mm2025-04-02
00888867514508Arthrex®ARTHREX, INC.AR-8964-252025-03-26
00888867514515Arthrex®ARTHREX, INC.AR-8964-262025-03-26
00840194480307Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-102025-03-18
00840194480314Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-152025-03-18
00840194480321Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-202025-03-18
00840194480338Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-252025-03-18
00840194480345Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-302025-03-18
00840194480352Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-352025-03-18
00840194480369Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-402025-03-18
00840194480376Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-452025-03-18
00840194480383Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-502025-03-18
00840194480390Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-552025-03-18
00840194480406Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB40-200-602025-03-18
00840194480413Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB50-200-102025-03-18
00840194480420Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB50-200-152025-03-18
00840194480437Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB50-200-202025-03-18
00840194480444Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB50-200-252025-03-18
00840194480451Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB50-200-302025-03-18
00840194480468Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB50-200-352025-03-18
00840194480475Orthex External Fixation SystemORTHOPEDIATRICS CORP.SB50-200-402025-03-18