BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

    K Number: K011390 · Decision Jun 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    16
    Review Days
    30

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    Basic Information

    Device Name
    BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
    K Number
    K011390
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disc-O-Tech Medical Technologies, Ltd.
    Date Received
    May 7, 2001
    Decision Date
    June 6, 2001
    Product Code
    MBI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Disc-O-Tech Medical Technologies, Ltd.

    K Number Device Name
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    K063067 CONFIDENCE FENESTRATED INTRODUCER NEEDLE
    K062424 CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
    K060300 CONFIDENCE HIGH VISCOSITY BONE CEMENT
    K040612 SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    K040939 SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    K032730 FIXION HIP SYSTEM
    K034037 SKY BONE EXPANDER SYSTEM
    K032358 B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
    Search all 16 clearances from Disc-O-Tech Medical Technologies, Ltd. →