FDA.reportPublic FDA data

Bone nail guidewire, single-use

Definition
A sterile, long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a single-use device.
GUDID devices
53
Last updated
2023-09-07 10:22:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
23596010121640LARGE CANNULATED SCREWSSmith & Nephew, Inc.4102362018-02-14
03596010514851TRIGENSmith & Nephew, Inc.717511462015-08-25
00885556828694Panta 2 Arthrodesis Nail SystemSmith & Nephew, Inc.PAN-1010-00342023-01-19
10381780505501Panta® 2Ascension Orthopedics, Inc.PAN-1010-00342018-11-13
00885556885451TrigenSmith & Nephew, Inc.XT001174-22022-09-19
B058ODID103NS1Trocar Tip Guide WireOrthopedic Designs North America, Inc.ODID103NS2022-08-17
B058ODID105NS1Trocar Tip Guide WireOrthopedic Designs North America, Inc.ODID105NS2022-08-17
B058ODID1031Trocar Tip Guide WireOrthopedic Designs North America, Inc.ODID1032022-08-16
B058ODID1041Lag Guide PinOrthopedic Designs North America, Inc.ODID1042022-08-16
B058ODID1051Trocar Tip Guide WireOrthopedic Designs North America, Inc.ODID1052022-08-16
05060464140327Quick-StartINNOVATE ORTHOPAEDICS LIMITED100252022-07-15
00822409104130n/aOrtho Development Corporation880-00132022-05-01
00822409104222n/aOrtho Development Corporation880-00112022-05-01
00822409104239n/aOrtho Development Corporation880-00122022-05-01
00822409111244n/aOrtho Development Corporation880-0011A2022-05-01
00822409111251n/aOrtho Development Corporation880-0012A2022-05-01
00822409111268n/aOrtho Development Corporation880-0013A2022-05-01
10886705021970NAMedos International Sàrl2141522015-09-01
10886705027675NAMedos International Sàrl2548442016-12-15
20886705013057NADEPUY MITEK, LLC2545142015-09-01
20886705027665NAMedos International Sàrl2548432016-12-15
10855068008119Guidewire KitCURVAFIX, INC.CGK-0012021-08-11
00885556809624TrigenSmith & Nephew, Inc.E0017425-22021-06-08
10886982297075NASynthes GmbH03.043.013S2021-05-25
07612334168573NASYNTHES (U.S.A.) LP03.045.0182021-05-05
008100743003842.70 Guide Wire Drill Tip SS 450mmOsteocentric Technologies, Inc.2004-00282021-02-12
008100743003912.70 Guide Wire Thd SS 450mmOsteocentric Technologies, Inc.2004-00292021-02-12
008169500279632.7mm Guidewire, Threaded Trocar Tip, 300mmOsteocentric Technologies, Inc.2004-00152020-06-17
05391529583118ApexORTHOXEL DESIGNATED ACTIVITY COMPANYINS-1069S2021-02-05
00816950027949Stylet, 285mmOsteocentric Technologies, Inc.2004-00112020-06-17
008169500279562.7mm Guidewire, Drill Tip, 300mmOsteocentric Technologies, Inc.2004-00142020-06-17
B26711000200Flow-Drill™Flow-FX110-00-202020-12-18
B26711000280Flow-Drill™Flow-FX110-00-282020-12-18
00889795061577Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-955-1800-S2020-12-15
00889795097859Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.P31-951-30322020-12-15
00889795097866Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-951-01992020-12-15
03596010529107TRIGENSmith & Nephew, Inc.716316262015-08-30
10381780364214Integra®Ascension Orthopedics, Inc.WIRE0930501S2019-12-13
10381780364221Integra®Ascension Orthopedics, Inc.WIRE0930501T2019-12-13
20806378114271ACUMEDAcumed LLC45-0086-S2019-06-10
20806378114288ACUMEDAcumed LLC45-0087-S2019-06-10
20806378114295ACUMEDAcumed LLC45-0088-S2019-06-10
B058ODID1011Ball Tip Sheathed Guide WireOrthopedic Designs North America, Inc.ODID1012018-03-26
B058ODID1021Trocar Tip WireOrthopedic Designs North America, Inc.ODID1022018-03-23
B058SLNT331Trocar Tip WireOrthopedic Designs North America, Inc.SLNT332018-03-26
B058SLNT341Round Tip WireOrthopedic Designs North America, Inc.SLNT342018-03-26
B058SLNT351Trocar Tip WireOrthopedic Designs North America, Inc.SLNT352018-03-26
B058SLNT361Round Tip WireOrthopedic Designs North America, Inc.SLNT362018-03-26
B058SLNT411Ball Tip Sheathed Guide WireOrthopedic Designs North America, Inc.SLNT412018-03-26
B058SLNT421Lag Guide PinOrthopedic Designs North America, Inc.SLNT422018-03-27
B058THNT341Ball Tip WireOrthopedic Designs North America, Inc.THNT342018-03-27
00817329023258CorticaLINK MILINKSPINE, INC.80-47152018-04-24
00817329023265CorticaLINK MILINKSPINE, INC.80-47162018-04-24