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510(k) Data Aggregation

    K Number
    K002600
    Device Name
    LITWIN CRUICATE ANCHOR
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    2000-11-15

    (86 days)

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

    INSTRUMENT MAKAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980999
    Device Name
    ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1998-11-06

    (233 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENT MAKAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The specific intended use of the St. Leger total knee implant is for patients suffering from pain and/or deformity of the knee joint. The pathological conditions include, but are not parted to severe degenerative arthritis, traumatic arthritis, inflammatory arthritis, and rheumatoid arthritis. The symptomatic problems include pain, decreased ambulation, inability to work, perform activities of daily living. The resulting physical deformities include loss of knee extension, knee flexion, genu valgum and genu varus. The implant may be used in revision knee surgery due to loosening, infection, or prior implant failure if the proper accompanying conditions are present and the surgeon is able to make the necessary anatomical conditions for acceptable alignment and fixation.
    Device Description
    Not Found
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    K Number
    K963396
    Device Name
    BIOSPHERE SUTURE ANCHOR
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1997-05-06

    (251 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENT MAKAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964364
    Device Name
    DISPOSABLE APRON
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1997-02-25

    (116 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENT MAKAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.
    Device Description
    The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
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    K Number
    K955835
    Device Name
    FLUID BARRIER BOOT KNEE & ANKLE-HIGH
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1996-11-19

    (329 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENT MAKAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
    Device Description
    The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.
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    K Number
    K960555
    Device Name
    BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1996-07-09

    (151 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENT MAKAR, INC.

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

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