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

    LACTOSORB POP RIVET

    K Number: K951658 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    5
    Review Days
    106

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    Basic Information

    Device Name
    LACTOSORB POP RIVET
    K Number
    K951658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Poly-Medics,Inc.
    Date Received
    April 10, 1995
    Decision Date
    July 25, 1995
    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 Poly-Medics,Inc.

    K Number Device Name
    K960988 LACTOSORB TRAUMA PLATING SYSTEM
    K955729 LACTOSORB TRAUMA PLATING SYSTEM
    K954443 LACTOSORB SUTURE ANCHOR
    K934861 HARD TISSUE REPLACEMENT (HTR) GRANULAR