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510(k) Data Aggregation

    K Number
    K142339
    Device Name
    HEMASORB Resorbable Hemostatic Bone Putty
    Manufacturer
    ORTHOCON, LLC
    Date Cleared
    2014-09-26

    (36 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOCON, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthocon HEMASORBpress Resorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. HEMASORBpress Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
    Device Description
    Orthocon HEMASORBpress™ Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, resorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling properties) and an alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature. When applied manually to surgically incised or traumatically broken bone, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and resorbed within a period of 30 days.
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    K Number
    K043260
    Device Name
    ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
    Manufacturer
    ORTHOCON, LLC
    Date Cleared
    2005-08-12

    (261 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOCON, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthocon OrthoStat™ Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.
    Device Description
    Orthocon OrthoStat™ Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling properties) and alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature. When applied manually to surgically incised or traumatically broken bone, OrthoStat Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.
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