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510(k) Data Aggregation

    K Number
    K162570
    Device Name
    Miromatrix Biological Mesh TW
    Manufacturer
    Miromatrix Medical Inc.
    Date Cleared
    2017-02-16

    (154 days)

    Product Code
    FTM, OWW
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Miromatrix Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miromatrix Biological Mesh TW is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
    Device Description
    The Miromatrix Biological Mesh TW is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The Miromatrix Biological Mesh TW provides a scaffold during tissue repair and is designed to be an interface between the tendon and tendon sheath or the surrounding tissues. The Miromatrix Biological Mesh TW is designed for placement under, around or over the injured tendon. The device is terminally sterilized by electron beam irradiation in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 10 cm x 20 cm, and may be trimmed or cut as required before being sutured to the surgical site.
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    K Number
    K160400
    Device Name
    Miromatrix Biological Mesh
    Manufacturer
    MIROMATRIX MEDICAL INC.
    Date Cleared
    2016-06-08

    (117 days)

    Product Code
    OXH, FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIROMATRIX MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
    Device Description
    The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
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    K Number
    K150341
    Device Name
    Miromatrix Biological Mesh RS
    Manufacturer
    MIROMATRIX MEDICAL INC.
    Date Cleared
    2015-05-12

    (90 days)

    Product Code
    OXH
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIROMATRIX MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
    Device Description
    The Miromatrix Biological Mesh RS is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
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    K Number
    K143426
    Device Name
    Wound Matrix TF
    Manufacturer
    MIROMATRIX MEDICAL INC.
    Date Cleared
    2015-01-27

    (57 days)

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

    MIROMATRIX MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wound Matrix TF is intended for the management of wounds including: - · Partial and full thickness wounds; - · Pressure ulcers; - Venous ulcers: - · Diabetic ulcers; - Chronic vascular ulcers; - · Tunneled, undermined wounds; - · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence); - · Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears); - · Draining wounds. The device is supplied sterile and is intended for one-time use.
    Device Description
    Wound Matrix TF is an animal-sourced, acellular wound dressing that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting wound dressing is comprised primarily of collagen type I. The device is intended for use in the management of wounds. Wound Matrix TF is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The dressing is available in sizes ranging from 1 cm x 2 cm to 10 cm x 25 cm, and may be trimmed or cut as required.
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    K Number
    K140510
    Device Name
    MIROMATRIX WOUND MATRIX
    Manufacturer
    MIROMATRIX MEDICAL INC.
    Date Cleared
    2014-06-19

    (111 days)

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

    MIROMATRIX MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miromatrix Wound Matrix is intended for the management of wounds including: - Partial and full thickness wounds; - Pressure ulcers; - Venous ulcers; - Diabetic ulcers; - Chronic vascular ulcers; - Tunneled, undermined wounds; - Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence); - Trauma wounds (abrasions, lacerations, second-degree bums, and skin tears); - Draining wounds.
    Device Description
    The Miromatrix Wound Matrix is an animal-sourced, acellular wound dressing that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting wound dressing is comprised primarily of collagen type I. The device is intended for use in the management of wounds. The Miromatrix Wound Matrix is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The dressing is available in sizes ranging from 1 cm x 2 cm to 10 cm x 25 cm, and may be trimmed or cut as required.
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    K Number
    K134033
    Device Name
    MIROMATRIX BIOLOGICAL MESH
    Manufacturer
    MIROMATRIX MEDICAL INC.
    Date Cleared
    2014-03-31

    (90 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIROMATRIX MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue.
    Device Description
    The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The Miromatrix Biological Mesh is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
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