BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR

    K Number: K093428 · Decision Dec 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    18
    Review Days
    44

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    Basic Information

    Device Name
    SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
    K Number
    K093428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Endoscopy, Inc.
    Date Received
    November 3, 2009
    Decision Date
    December 17, 2009
    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 Smith & Nephew Endoscopy, Inc.

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    K083226 SMITH & NEPHEW PEEK INTERFERENCE SCREW
    K082095 ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
    K050580 SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
    K992396 BIORCI SCREW
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    K972599 ACUFEX SCREW CANNULA
    K971939 SMITH & NEPHEW SUTURE COLLET
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