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510(k) Data Aggregation

    K Number
    K162965
    Device Name
    SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
    Manufacturer
    TEI Biosciences Inc.
    Date Cleared
    2017-02-16

    (115 days)

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

    TEI Biosciences Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: - · Plastic and reconstructive surgery - · Muscle flap reinforcement - · Hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
    Device Description
    SurgiMend is an acellular dermal tissue derived from bovine dermis. The device is available in solid, fenestrated, and perforated configurations. The device is supplied sterile in a variety of sizes, shapes, and thicknesses.
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    K Number
    K153690
    Device Name
    PriMatrix Dermal Repair Scaffold
    Manufacturer
    TEI BioSciences Inc.
    Date Cleared
    2016-02-22

    (61 days)

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

    TEI BioSciences Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PriMatrix is intended for the management of wounds that include: - Partial and full thickness wounds - Pressure, diabetic, and venous ulcers - Second-degree burns - Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence - Trauma wounds abrasions, lacerations and skin tears - Tunneled/undermined wounds - Draining wounds
    Device Description
    PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surqeon to meet the individual patient's needs.
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    K Number
    K131286
    Device Name
    PRIMATRIX DERMAL REPAIR SCAFFOLD
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2013-08-05

    (91 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PriMatrix is intended for the management of wounds that include: - Partial and full thickness wounds - Pressure, diabetic, and venous ulcers - Second-degree burns - Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence - Trauma wounds-abrasions, lacerations, and skin tears - Tunneled/undermined wounds - Draining wounds
    Device Description
    PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
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    K Number
    K100261
    Device Name
    PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2010-12-10

    (316 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PriMatrix Ag Antimicrobial is intended for the management of wounds that include: - Partial and full thickness wounds - Pressure, diabetic, and venous ulcers - Second-degree burns - Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence - Trauma wounds-abrasions, lacerations, and skin tears - Tunneled/undermined wounds - Draining wounds
    Device Description
    PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine dermis. PriMatrix Ag Antimicrobial is supplied sterile in a variety of sizes that can be trimmed by the surgeon to meet the individual patient's needs. The Ionic Silver content is intended to prevent microbial colonization of the device.
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    K Number
    K083898
    Device Name
    SURGIMEND
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2009-02-04

    (37 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery Muscle flap reinforcement Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias
    Device Description
    SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
    Ask a Question
    K Number
    K083440
    Device Name
    PRIMATRIX DERMAL REPAIR SCAFFOLD
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2008-12-12

    (22 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PriMatrix is intended for the management of wounds that include: - . Partial and full thickness wounds - . Pressure, diabetic, and venous ulcers - . Second-degree burns - . Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence - . Trauma wounds-abrasions, lacerations, and skin tears - . Tunneled/undermined wounds - Draining wounds .
    Device Description
    PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
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    K Number
    K071807
    Device Name
    ORTHOMEND SOFT TISSUE MATRIX
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2007-08-06

    (35 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery, Muscle flap reinforcement, Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias, Reinforcement of soft tissues repaired by sutures or sutures anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
    Device Description
    SurgiMend is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
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    K Number
    K061407
    Device Name
    PRIMATRIX DERMAL REPAIR SCAFFOLD
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2006-06-29

    (38 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PriMatrix is intended for the management of wounds that include: - Partial and full thickness wounds . - Pressure, diabetic, and venous ulcers . - Second-degree burns . - Surgical wounds-donor sites/grafts, post-moh's surgery, post-laser surgery, . podiatric, wound dehiscence - Trauma wounds-abrasions, lacerations, and skin tears . - Tunneled/undermined wounds . - Draining wounds .
    Device Description
    PriMatrix is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed by the surgeon to meet the individual patient's needs.
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    K Number
    K060829
    Device Name
    COSMATRIX
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2006-05-17

    (51 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CosMatrix is 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
    CosMatrix is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
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    K Number
    K060984
    Device Name
    XENFORM SOFT TISSUE REPAIR MATRIX
    Manufacturer
    TEI BIOSCIENCES INC.
    Date Cleared
    2006-05-17

    (37 days)

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

    TEI BIOSCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.
    Device Description
    Xenform Soft Tissue Repair Matrix is an acellular collagen material intended to be utilized for surgical procedures pertaining to the pelvic floor. Xenform Soft Tissue Repair Matrix is supplied sterile and provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs. Xenform Soft Tissue Repair Matrix is manufactured from bovine skin, one of the purest sources of collagen available. The source material is solely derived from cattle obtained in compliance with US and European regulatory requirements.
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