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510(k) Data Aggregation

    K Number
    K213777
    Device Name
    Stryker Resorbable Fixation System
    Manufacturer
    Stryker Leibinger Micro Implants
    Date Cleared
    2022-02-04

    (63 days)

    Product Code
    JEY, GXR, HBW
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Leibinger Micro Implants

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental: The Delta Resorbable Fixation System is intended for use in the fixation of bones of the maxillofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients. Neuro: The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.
    Device Description
    The Stryker Resorbable Fixation System is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide.
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    K Number
    K051603
    Device Name
    STRYKER INJECTABLE CEMENT
    Manufacturer
    STRYKER LEIBINGER MICRO IMPLANTS
    Date Cleared
    2005-12-30

    (198 days)

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

    STRYKER LEIBINGER MICRO IMPLANTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
    Device Description
    Stryker® Injectable Cement is a self-setting calcium phosphate cement.
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