FDA.reportPublic FDA data

Orthopaedic surgical distractor, external

Definition
A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device.
GUDID devices
156
Last updated
2026-08-08 10:09:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850041805863X-PACEXPANDING INNOVATIONS, INC.EI26082026-07-30
00841731153104ARTEMIS FUZEVILEX LLCAFZ-COMP2026-07-22
00888867216181Arthrex®ARTHREX, INC.AR-8948CD2018-10-26
B803904210SS0ORTHOMEDORTHO-MED, INC.OM 90-4210-SS2026-05-08
00696588008257De Mayo Universal Distractor®Innovative Medical Products, Inc621AS2026-01-20
00810130207329MSIModern Surgical Instruments LLCFSP10012025-12-23
00840277132871Innomed, Inc.INNOMED, INC.4216-SS-042025-10-14
00696588008110De Mayo Universal Distractor®Innovative Medical Products, Inc907AS2025-08-11
00810021866604In2BonesIn2Bones USA, LLCC01 N10322024-12-10
00810021866864In2BonesIn2Bones USA, LLCC01 N10312024-12-10
00810021866871In2BonesIn2Bones USA, LLCC01 N00012024-12-10
00190776404765MillenniumAvalign Technologies, Inc.1-4215SSC2025-07-10
00810021862156In2BonesIn2Bones USA, LLCP08 N00112024-12-12
00810021862163In2BonesIn2Bones USA, LLCP08 N00212024-12-12
00810021862255In2BonesIn2Bones USA, LLCP08 N00912024-12-12
00810021862262In2BonesIn2Bones USA, LLCP08 N01012024-12-12
00810021865959In2BonesIn2Bones USA, LLCP07 N01712024-12-12
00810021865966In2BonesIn2Bones USA, LLCP07 N01812024-12-12
00810021865973In2BonesIn2Bones USA, LLCP07 N01912024-12-12
00810021865980In2BonesIn2Bones USA, LLCP07 N02012024-12-12
00810021865997In2BonesIn2Bones USA, LLCP07 N02112024-12-12
00810021866000In2BonesIn2Bones USA, LLCP07 N02212024-12-12
00810021866017In2BonesIn2Bones USA, LLCP07 N02612024-12-12
00810021866024In2BonesIn2Bones USA, LLCP07 N02712024-12-12
00810021866031In2BonesIn2Bones USA, LLCP07 N02812024-12-12
00810021869445In2BonesIn2Bones USA, LLCP06 N06512024-12-12
008100218694215MSIn2Bones USA, LLCP06 N02212024-12-09
00840314269669gSourceGSOURCE LLCgS 40.11602024-10-25
00191083047393AlloWedgeRti Surgical, Inc.55-DISTRACTOR2024-10-14
00191083047409AlloWedgeRti Surgical, Inc.55-DISTRACTORNRW2024-10-14
00190776384067MillenniumAvalign Technologies, Inc.1-17512024-08-20
00858325005701Gauthier BiomedicalGAUTHIER BIOMEDICAL, INC.5161-00-5052 (G602227)2023-11-28
00190776304652MillenniumAvalign Technologies, Inc.1-42332023-11-16
00190776306519MillenniumAvalign Technologies, Inc.1-17522023-11-16
00810111222006Compressor / DistractorTreace Medical Concepts, Inc.01-1000-0272023-11-13
00810111221801Compressor / DistractorTreace Medical Concepts, Inc.01-1000-0032023-11-10
00840277129048Innomed, Inc.INNOMED, INC.8990-GPR2023-08-28
00696588007458De Mayo Universal Distractor®Innovative Medical Products, Inc907-62023-07-05
00696588007465De Mayo Universal Distractor®Innovative Medical Products, Inc907-112023-07-05
00696588007441Demo De Mayo Universal Distractor® 2.0Innovative Medical Products, Inc621-DEMO2023-06-22
00696588007434De Mayo Universal Distractor® 2.0Innovative Medical Products, Inc621-LOANER2023-06-12
00850001720557X-PACEXPANDING INNOVATIONS, INC.EI30142023-05-26
00696588007403De Mayo Universal Distractor®Innovative Medical Products, Inc621-P2023-05-09
00810130201853MSIModern Surgical Instruments LLC742-022023-03-30
00810130201860MSIModern Surgical Instruments LLC742-122023-03-30
00810130201785MSIModern Surgical Instruments LLC96-01362023-03-28
00810130201792MSIModern Surgical Instruments LLC96-01372023-03-28
00810130201808MSIModern Surgical Instruments LLC96-01392023-03-28
00810130201815MSIModern Surgical Instruments LLC96-01402023-03-28
00696588007151De Mayo Universal Distractor®Innovative Medical Products, Inc6212022-11-28
00840343714239GEN2SURGIX MEDICAL LLCG2N528042022-11-11
00840343714246GEN2SURGIX MEDICAL LLCG2N528032022-11-11
00696588000978Reznik Universal Shoulder Positioner™Innovative Medical Products, Inc9082022-10-24
00696588002484Reznik Universal Shoulder Positioner™Innovative Medical Products, Inc908 KIT2022-10-24
00696588006109Reznik Universal Shoulder Positioner™Innovative Medical Products, Inc908-DEMO2022-10-24
B4198100870MSIModern Surgical Instruments LLC81-00872022-10-04
00840314216892gSourceGSOURCE LLCgS 40.11502019-12-17
00840314217462gSourceGSOURCE LLCgS 40.35552019-12-18
00840314217516gSourceGSOURCE LLCgS 40.36652019-12-18
00810111220408Compressor & DistractorTreace Medical Concepts, Inc.1405-25512022-09-12
00810111221030Compressor & DistractorTreace Medical Concepts, Inc.1405-22682022-09-12
00853114006709Compressor & DistractorTreace Medical Concepts, Inc.1405-22302022-09-12
00853114006785Compressor & DistractorTreace Medical Concepts, Inc.1405-23052022-09-12
00853114006969Compressor & DistractorTreace Medical Concepts, Inc.1405-24272022-09-12
00841379101222HALF DOMEAstura MedicalBZ03000032022-08-29
00841379101239HALF DOMEAstura MedicalBZ03000042022-08-29
00841379101246HALF DOMEAstura MedicalBZ03000052022-08-29
00841379101253HALF DOMEAstura MedicalBZ03000062022-08-29
00841379101260HALF DOMEAstura MedicalBZ03000072022-08-29
00841379101277HALF DOMEAstura MedicalBZ03000082022-08-29
00841379101284HALF DOMEAstura MedicalBZ03000092022-08-29
00841379101291HALF DOMEAstura MedicalBZ03000102022-08-29
00841379101307HALF DOMEAstura MedicalBZ03000112022-08-29
00841379101314HALF DOMEAstura MedicalBZ03000122022-08-29
00841379101321HALF DOMEAstura MedicalBZ03000132022-08-29
00841379101338HALF DOMEAstura MedicalBZ03000142022-08-29
00841379101345HALF DOMEAstura MedicalBZ03000152022-08-29
00840314217400gSourceGSOURCE LLCgS 40.34182019-12-18
00840314217417gSourceGSOURCE LLCgS 40.34282019-12-18
00840314217448gSourceGSOURCE LLCgS 40.35212019-12-18