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510(k) Data Aggregation

    K Number
    K111048
    Device Name
    SYNTHES SCOUT TACK FIXATION
    Manufacturer
    SYNTHES SPINE
    Date Cleared
    2012-06-14

    (426 days)

    Product Code
    OMR, NDM
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.
    Device Description
    The Synthes Scout Tack Fixation is a method of fixation of the Scout Vessel Guard to bone. The single-use Scout Tack implant is made of a titanium alloy (TAN, per ASTM F1295-05, "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)," January 1, 2005). It has a low profile head. The tack is inserted by light impaction through the Scout Vessel Guard into lumbar vertebral bone. The Scout Tack implant can be used as an alternative to, or a complement to, suturing the Scout Vessel Guard in place.
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    K Number
    K111137
    Device Name
    HYDROFIX VASO SHIELD
    Manufacturer
    MIMEDX GROUP INC
    Date Cleared
    2011-05-20

    (28 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery. Fusion surgery, Adjacent level surgery, Artificial Disc Implantation, Implant or Hardware Removal, Trauma, Vascular Surgery in the Spine.
    Device Description
    The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is slippery, clear, pliable, conformable, nanoporous permanent vessel cover that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
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    K Number
    K101805
    Device Name
    HYDROFIX VASO SHIELD
    Manufacturer
    MIMEDX GROUP, INC
    Date Cleared
    2011-04-08

    (284 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydroFix Vaso Shield™ is indicated for use as a cover for vessels following anterior vertebral surgery.
    Device Description
    The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is a slippery, clear pliable, conformable, nanoporous provided in valled over that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
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    K Number
    K103558
    Device Name
    SYNTHES SCOUT VESSEL GUARD
    Manufacturer
    SYNTHES SPINE
    Date Cleared
    2011-02-18

    (78 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
    Device Description
    The Scout Vessel Guard is a permanent, non-absorbable membrane made of hydrogel. It is packaged wet in phosphate buffered saline (PBS). This device is designed to be placed between the anterior spine and proximate vessels during anterior lumbar surgery, and is flexible, allowing it to contour to the anatomy. The Scout Vessel Guard can be affixed to bone and/or soft tissue.
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    K Number
    K101826
    Device Name
    HYDROFIX VASO SHIELD, MODEL HVS-001-0610
    Manufacturer
    MIMEDX GROUP, INC
    Date Cleared
    2010-07-28

    (27 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K100984
    Device Name
    XYLOS VESSEL GUARD
    Manufacturer
    XYLOS CORPORATION
    Date Cleared
    2010-07-07

    (90 days)

    Product Code
    OMR, PRE
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XYLOS™ Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
    Device Description
    XYLOS™ Vessel Guard is a flexible, non-resorbable, implantable sheet composed of microbialderived cellulose. The device is presented ready-to-use in a sterile double-pouched package. It is intended for one time use.
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    K Number
    K100905
    Device Name
    HYDROFIX SURGICAL SHEET
    Manufacturer
    MIMEDX GROUP, INC
    Date Cleared
    2010-06-02

    (62 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.
    Device Description
    The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
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    K Number
    K093551
    Device Name
    PARADIS VASO SHIELD
    Manufacturer
    SPINEMEDICA, LLC
    Date Cleared
    2009-12-24

    (37 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineMedica Paradis Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
    Device Description
    The SpineMedica Paradis Vaso Shield™ is a flexible sheet of 30 Wt.1% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.
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    K Number
    K090022
    Device Name
    PARADIS VASO SHIELD
    Manufacturer
    SPINEMEDICA, LLC
    Date Cleared
    2009-04-20

    (105 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineMedica Paradís Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
    Device Description
    The SpineMedica Paradís Vaso Shield™ is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.
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    K Number
    K082782
    Device Name
    REPLICATION MEDICAL VESSEL GUARD
    Manufacturer
    REPLICATION MEDICAL INC
    Date Cleared
    2009-04-02

    (192 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    OMR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.
    Device Description
    The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery. The Vessel Guard is available in several sizes and is manufactured from biocompatible materials.
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