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510(k) Data Aggregation

    K Number
    K251844
    Device Name
    Kerecis SurgiBind (50241)
    Manufacturer
    Kerecis Limited
    Date Cleared
    2025-07-15

    (29 days)

    Product Code
    OXH
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K202430
    Device Name
    Kerecis Reconstruct
    Manufacturer
    Kerecis Limited
    Date Cleared
    2021-05-02

    (250 days)

    Product Code
    OXH
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device is indicated for: For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.
    Device Description
    The subject device is a fish skin medical device indicated for physical reinforcement of a soft tissue defect or weakness. The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular solid sizes: 4x7 cm, 7x10 cm, 7x20 cm. The subject device is biocompatible, non-crosslinked, and therefore resorbable, strong, flexible, and supports fixation.
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    K Number
    K171357
    Device Name
    SurgiMend PRS Meshed, Revize-X
    Manufacturer
    Integra LifeSciences Corporation (Owner of TEI Biosciences)
    Date Cleared
    2017-06-07

    (29 days)

    Product Code
    OXH, FTM
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.
    Device Description
    SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.
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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?
    Product Code :

    OXH

    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?
    Product Code :

    OXH

    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.
    Ask a Question

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