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510(k) Data Aggregation

    K Number
    K192371
    Device Name
    BioZorb SP Marker
    Manufacturer
    Focal Therapeutics
    Date Cleared
    2019-09-26

    (27 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Focal Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioZorb SP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
    Device Description
    The BioZorb SP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb SP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb SP Marker is provided sterile for single use and is implantable.
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    K Number
    K171467
    Device Name
    BioZorb Marker GOLD / LP Marker GOLD
    Manufacturer
    Focal Therapeutics
    Date Cleared
    2017-11-09

    (175 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Focal Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
    Device Description
    The BioZorb Marker GOLD / LP Marker GOLD is an implantable radiopaque marker comprised of a bioabsorbable component and a permanent component. The BioZorb Marker GOLD / LP Marker GOLD is provided sterile for single use and is implantable.
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    K Number
    K152070
    Device Name
    BioZorb LP Marker
    Manufacturer
    FOCAL THERAPEUTICS
    Date Cleared
    2015-08-26

    (30 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOCAL THERAPEUTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioZorb LP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
    Device Description
    The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
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    K Number
    K143484
    Device Name
    BioZorb Marker
    Manufacturer
    FOCAL THERAPEUTICS
    Date Cleared
    2015-06-29

    (203 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOCAL THERAPEUTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
    Device Description
    The BioZorb Marker is an implantable radiopaque marker comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 or more years and a permanent component (titanium). The BioZorb Marker is provided sterile for single use and is implantable.
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    K Number
    K113202
    Device Name
    TISSUE MARKER
    Manufacturer
    FOCAL THERAPEUTICS
    Date Cleared
    2012-02-28

    (120 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOCAL THERAPEUTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioZorb™ Tissue Marker is indicated for radiographic marking of sites in soft tissue.
    Device Description
    The BioZorb Tissue Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb Tissue Marker is comprised of a bioabsorbable component and a permanent component. The BioZorb Tissue Marker is provided sterile for single use and is disposable.
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