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510(k) Data Aggregation

    K Number
    K173572
    Device Name
    DSM Biomedical Calcium Phosphate Cement with Microspheres
    Manufacturer
    Kensey Nash Corporation dba DSM Biomedical
    Date Cleared
    2018-05-09

    (170 days)

    Product Code
    MQV, MOV, OIS
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kensey Nash Corporation dba DSM Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the sketal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microsheres resorbs and is replaced by bone during the healing process.
    Device Description
    DSM Biomedical Calcium Phosphate Cement with Microspheres is an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement with Microspheres is composed of calcium phosphate which converts to hydroxyapatite in vivo, bovine collagen powder, and PLGA microspheres. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement with Microspheres is supplied sterile by gamma irradiation and is non-pyrogenic.
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    K Number
    K173362
    Device Name
    DSM Biomedical Calcium Phosphate Cement
    Manufacturer
    Kensey Nash Corporation dba DSM Biomedical
    Date Cleared
    2018-04-03

    (159 days)

    Product Code
    MQV, OIS
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kensey Nash Corporation dba DSM Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The DSM Biomedical Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The DSM Biomedical Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.
    Device Description
    DSM Biomedical Calcium Phosphate Cement as an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement is composed of calcium phosphate which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.
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    K Number
    K170245
    Device Name
    DSM Biomedical Dental Bone Graft
    Manufacturer
    Kensey Nash Corporation dba DSM Biomedical
    Date Cleared
    2017-05-16

    (110 days)

    Product Code
    NPM
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kensey Nash Corporation dba DSM Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DSM Biomedical Dental Bone Graft is indicated for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy, and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
    Device Description
    The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.
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    K Number
    K160474
    Device Name
    DSM Biomedical Porcine Pericardium Dental Membrane
    Manufacturer
    Kensey Nash Corporation dba DSM Biomedical
    Date Cleared
    2016-06-07

    (109 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kensey Nash Corporation dba DSM Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DSM Biomedical Porcine Pericardium Dental Membrane is indicated for: - simultaneous use of GBR-membrane and implants - augmentation around implants placed in immediate extraction sockets - augmentation around implants placed in delayed extraction sockets - localized ridge augmentation for later implantation - alveolar ridge reconstruction for prosthetic treatment - filling of bone defects after root resection, cystectomy, removal of retained teeth - guided bone regeneration in dehiscence defects - guided tissue regeneration procedures in periodontal defects.
    Device Description
    The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only. The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.
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    K Number
    K141738
    Device Name
    MEDEOR MATRIX WOUND DRESSING
    Manufacturer
    KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
    Date Cleared
    2015-02-17

    (235 days)

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

    KENSEY NASH CORPORATION DBA DSM BIOMEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medeor Matrix Wound Dressing is indicated for the management of topical 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. Medeor Matrix Wound Dressing is intended for one time use.
    Device Description
    Medeor Matrix Wound Dressing, Acellular Dermal Matrix is a resorbable porcine dermisderived dressing intended for the management of topical wounds. The device is sterilized by electron beam irradiation and supplied hydrated in a double layer package. The device is a prescription device for single use only.
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    K Number
    K133169
    Device Name
    MESO TENDON MATRIX
    Manufacturer
    KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
    Date Cleared
    2013-12-20

    (64 days)

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

    KENSEY NASH CORPORATION DBA DSM BIOMEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Meso Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon Matrix 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. Meso Tendon Matrix is supplied sterile and for one time use.
    Device Description
    Meso Tendon Matrix is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine mesothelium tissue. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.
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    K Number
    K132025
    Device Name
    MESO BILAYER SURGICAL MESH
    Manufacturer
    KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
    Date Cleared
    2013-10-30

    (121 days)

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

    KENSEY NASH CORPORATION DBA DSM BIOMEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.) Meso Bilayer Surgical Mesh is supplied sterile and for one time use.
    Device Description
    Meso Bilayer Surgical Mesh is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine tissue and a synthetic absorbable polymer. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.
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