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

    ENDOBUTTON CONTINUOUS LOOP (CL)

    K Number: K081098 · Decision Jul 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    ENDOBUTTON CONTINUOUS LOOP (CL)
    K Number
    K081098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Inc., Endoscopy Division
    Date Received
    April 17, 2008
    Decision Date
    July 16, 2008
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    Other Clearances by Smith & Nephew Inc., Endoscopy Division

    K Number Device Name
    K121904 GYNECOLOGY STERILIZATION TRAY
    K102982 ENDOBUTTON DIRECT
    K082215 OSTEORAPTOR SUTURE ANCHOR
    K072785 TWINFIX FT PK
    K071586 BIORAPTOR 2.3 PK SUTURE ANCHOR
    K070908 SMITH & NEPHEW KINSA RC SUTURE ANCHOR
    K070167 ENDOBUTTON DIRECT