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510(k) Data Aggregation

    K Number
    K072170
    Device Name
    WELLGRAFT PE II
    Date Cleared
    2008-04-04

    (242 days)

    Product Code
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    GWOWEI TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WELLGRAFT PE II Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. WELLGRAFT PE II Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
    Device Description
    The WELLGRAFT PE II Resorbable Bone Void Filler consists of high purity mixed grade calcium sulfate hemihydrate powder with different size calcium sulfate granules, and mixing solution. When mixed according to the directions, WELLGRAFT PE II Resorbable Bone Void Filler forms the biodegradable, biocompatible and radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. WELLGRAFT PE II is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.
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    K Number
    K072444
    Device Name
    WELLGRAFT PE I
    Date Cleared
    2008-04-04

    (242 days)

    Product Code
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    GWOWEI TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WELLGRAFT PE I Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. Wellgraft PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
    Device Description
    The WELLGRAFT PE I Resorbable Bone Void Filler consists of high purity grade calcium sulfate hemihydrate powder and mixing solution. When mixed according to the directions, WELLGRAFT PE I Resorbable Bone Void Filler forms the biodegradable, biocompatible and rediopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. WELLGRAFT PE I Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 60~90 days and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.
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