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510(k) Data Aggregation

    K Number
    K023963
    Device Name
    ADHOC CLAW
    Manufacturer
    FUTURE MEDICAL SYSTEMS, INC.
    Date Cleared
    2003-05-05

    (157 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery.
    Device Description
    The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery. The ADHOC® CLAW is made of 316L stainless steel.
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    K Number
    K021030
    Device Name
    TITANIUM CANNULATED INTERFERENCE SCREW
    Manufacturer
    FUTURE MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-06-25

    (88 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during cruciate ligament repair through arthroscopy or arthrotomy.
    Device Description
    The titanium cannulated interference screw is tapered and has a smooth threaded design, which provides interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in lengths between 20 and 50 mm and diameters between 7mm and 12mm, resulting in a screw adapted to the morphology of the graft and patient.
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    K Number
    K013685
    Device Name
    PLLA CANNULATED INTERFERENCE SCREW
    Manufacturer
    FUTURE MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-01-18

    (72 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002040
    Device Name
    FMS SOLO
    Manufacturer
    FUTURE MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-09-11

    (68 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980808
    Device Name
    ENDO FMS UROLOGY
    Manufacturer
    FUTURE MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-05-08

    (66 days)

    Product Code
    LJH
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDO FMS® UROLOGY is a fluid management system used to maintain adequate irrigation pressure and flow in endoscopic Urology procedures, including all endoscopic procedures in the Kidney, Ureter/Urethra , Bladder and Prostate.
    Device Description
    ENDO FMS® UROLOGY is a fluid management system.
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    K Number
    K955500
    Device Name
    FMS ARTHOPROBE
    Manufacturer
    FUTURE MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-02-05

    (66 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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