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

    OsteoSeal Bone Hemostat

    K Number: K142348 · Decision Jan 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    10
    Review Days
    154

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    Basic Information

    Device Name
    OsteoSeal Bone Hemostat
    K Number
    K142348
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemostasis, LLC
    Date Received
    August 22, 2014
    Decision Date
    January 23, 2015
    Product Code
    MTJ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MTJ Wax, Bone

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    Other Clearances by Hemostasis, LLC

    K Number Device Name
    K234131 Resolv Endoscopic Hemostat System
    K220326 PosiSep X BAM Hemostat Dressing/Intranasal Splint
    K210411 PosiSep EAR Fragmentable Ear Dressing
    K122494 POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
    K122886 NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
    K120958 POSISEP AND POSISEP X HEMOSTAT DRESSINGS
    K102459 NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
    K072900 EXCELARREST FOAM
    K070211 TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM