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510(k) Data Aggregation

    K Number
    K011603
    Device Name
    VHS PEDIATRIC HIP SCREW SYSTEM
    Manufacturer
    WALTER ABENDSCHEIN, M.D.
    Date Cleared
    2001-08-15

    (83 days)

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

    WALTER ABENDSCHEIN, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows : 1. Congenital coxa vara. 2. Congenital dislocation of the hip 3. Subluxation or dislocation secondary to neurologic disorders, such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities. 4. Coxa plana ( Legg-Calve-Perthes disease )
    Device Description
    The VHS™ Pediatric Hip Screw System is a compression fixation system used for the treatment of femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws. Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
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    K Number
    K002184
    Device Name
    COD COMPRESSION OSTEOTOMY DEVICE
    Manufacturer
    WALTER ABENDSCHEIN, M.D.
    Date Cleared
    2000-11-24

    (128 days)

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

    WALTER ABENDSCHEIN, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000827
    Device Name
    UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
    Manufacturer
    WALTER ABENDSCHEIN, M.D.
    Date Cleared
    2000-06-23

    (101 days)

    Product Code
    KRR
    Regulation Number
    888.3540
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALTER ABENDSCHEIN, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991806
    Device Name
    VHS SUPRACONDYLAR PLATE SYSTEM
    Manufacturer
    WALTER ABENDSCHEIN, M.D.
    Date Cleared
    1999-08-06

    (72 days)

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

    WALTER ABENDSCHEIN, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.
    Device Description
    The VHS™ Supracondylar Plate System is a compression fixation system used for the treatment of distal femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws. Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
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    K Number
    K964880
    Device Name
    VARI-ANGLE HIP SCREW (VHS) SYSTEM
    Manufacturer
    WALTER ABENDSCHEIN, M.D.
    Date Cleared
    1997-10-16

    (315 days)

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

    WALTER ABENDSCHEIN, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vari-Angle Hip Screw is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.
    Device Description
    The Vari-Angle Hip Screw System is a compression hip fixation system used for the treatment of femoral neck fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
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