FDA.reportPublic FDA data

External orthopaedic fixation system noninvasive component, single-use

Definition
A noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.
GUDID devices
456
Last updated
2026-06-18 06:05:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10886982200716NASynthes GmbH395.7802015-09-14
00190446914020EF1Medshape, Inc.DNE-1000-WFB32026-04-01
00190446914563EF1Medshape, Inc.DNE-6000-0402026-04-01
00817867021013Drive RailORTHOPEDIATRICS CORP.21-10502025-10-17
00817867021020Drive RailORTHOPEDIATRICS CORP.21-11002025-10-17
00817867021037Drive RailORTHOPEDIATRICS CORP.22-20062025-10-17
00841731152060DYNEX VILEX LLCDXT-TTT-012026-05-15
00841731152237DYNEX VILEX LLCDXT-TTT-182026-05-15
00841731152268DYNEX VILEX LLCDXT-TTT-212026-05-15
00841731152275DYNEX VILEX LLCDXT-TTT-222026-05-15
00888867500518Arthrex®ARTHREX, INC.95-98202026-04-23
00888867500525Arthrex®ARTHREX, INC.M7802026-04-23
00888867500532Arthrex®ARTHREX, INC.M7812026-04-23
00888867500549Arthrex®ARTHREX, INC.M7822026-04-23
00888867500556Arthrex®ARTHREX, INC.M7832026-04-23
00888867500563Arthrex®ARTHREX, INC.M7842026-04-23
00888867500570Arthrex®ARTHREX, INC.M7882026-04-23
00888867500587Arthrex®ARTHREX, INC.M7902026-04-23
00888867500594Arthrex®ARTHREX, INC.M7912026-04-23
00888867500600Arthrex®ARTHREX, INC.M7962026-04-23
00888867500617Arthrex®ARTHREX, INC.M7972026-04-23
00888867500624Arthrex®ARTHREX, INC.M9012026-04-23
00888867500631Arthrex®ARTHREX, INC.M9022026-04-23
00888867500648Arthrex®ARTHREX, INC.M9032026-04-23
00888867500679Arthrex®ARTHREX, INC.M9082026-04-23
00889795152114Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-113-01202026-05-06
00889795152121Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-113-01402026-05-06
00889795152138Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-113-01602026-05-06
00889795152145Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-113-01802026-05-06
00889795152152Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-113-02002026-05-06
00889795152169Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-113-02202026-05-06
00889795152367Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-334-10002026-05-06
00889795152374Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-334-10012026-05-06
00889795152565Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-913-20022026-05-06
00889795152572Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-913-20122026-05-06
00889795152589Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-913-20202026-05-06
00889795152596Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-920-10012026-05-06
00889795152602Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-921-10012026-05-06
00889795152633Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-940-00022026-05-06
00889795152800Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-970-30252026-05-06
00889795152817Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-970-30552026-05-06
00889795152824Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-970-30852026-05-06
00889795152831Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-980-00102026-05-06
00889795152848Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-980-00152026-05-06
00889795152855Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-980-20002026-05-06
00889795152862Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-990-00012026-05-06
00889795152879Monkey Rings™ External Fixation SystemParagon 28, Inc.P45-990-00022026-05-06
07613327072402HOFFMANNStryker GmbH4922-1-0022016-09-24
07613327072426HOFFMANNStryker GmbH4922-1-0032016-09-24
10886982006653NASynthes GmbHSD394.8702015-09-14
10886982077585NASynthes GmbH03.301.010S2015-09-14
10886982077592NASynthes GmbH03.301.011S2015-09-14
10886982077608NASynthes GmbH03.301.012S2015-09-14
10886982077615NASynthes GmbH03.301.013S2015-09-14
10886982077905NASynthes GmbH03.311.0152015-09-14
10886982077912NASynthes GmbH03.311.0202015-09-14
10886982077929NASynthes GmbH03.311.0222015-09-14
10886982077936NASynthes GmbH03.311.0232015-09-14
10886982077943NASynthes GmbH03.311.0242015-09-14
10886982077950NASynthes GmbH03.311.0252015-09-14
10886982078087NASynthes GmbH03.311.0502015-09-14
10886982078094NASynthes GmbH03.311.0512015-09-14
10886982078100NASynthes GmbH03.311.0542015-09-14
10886982078117NASynthes GmbH03.311.0552015-09-14
10886982078124NASynthes GmbH03.311.0562015-09-14
10886982078216NASynthes GmbH03.311.0812015-09-14
10886982078223NASynthes GmbH03.311.0822015-09-14
10886982078230NASynthes GmbH03.311.0842015-09-14
10886982078278NASynthes GmbH03.311.1062015-09-14
10886982078285NASynthes GmbH03.311.1082015-09-14
10886982078292NASynthes GmbH03.311.1102015-09-14
10886982078308NASynthes GmbH03.311.1122015-09-14
10886982078315NASynthes GmbH03.311.1152015-09-14
10886982078322NASynthes GmbH03.311.1202015-09-14
10886982078339NASynthes GmbH03.311.1252015-09-14
10886982078346NASynthes GmbH03.311.1302015-09-14
10886982078353NASynthes GmbH03.311.1352015-09-14
10886982078360NASynthes GmbH03.311.1402015-09-14
10886982078377NASynthes GmbH03.311.1712015-09-14
10886982078384NASynthes GmbH03.311.1722015-09-14