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510(k) Data Aggregation

    K Number
    K090288
    Device Name
    ORTHADAPT PR
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Date Cleared
    2009-05-05

    (89 days)

    Product Code
    FTL, FTM, OWX, OXA, OXD
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PEGASUS BIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias. suture-line reinforcement and other reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. OrthADAPT® PR 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
    OrthADAPT® PR is comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, which is derived from the same equine pericardial tissue used in the fabrication of its predicate device, the OrthADAPT® Bioimplant, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.
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    K Number
    K071425
    Device Name
    UNITE BIOMATRIX
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Date Cleared
    2007-06-20

    (28 days)

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

    PEGASUS BIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: - Partial and full thickness wounds, . - Draining wounds, . - Pressure sores/ulcers, ◆ - Venous ulcers, . - . Chronic vascular ulcers, - Diabetic ulcers, . - Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), ● - Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)
    Device Description
    The Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
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    K Number
    K071065
    Device Name
    ORTHADAPT BIOIMPLANT
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Date Cleared
    2007-05-04

    (18 days)

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

    PEGASUS BIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and other reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. OrthADAPT® 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, OrthADAPT® is intended for one-time use only.
    Device Description
    The OrthADAPT Bioimplant is a decellularized, equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
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    K Number
    K061494
    Device Name
    DERMADAPT WOUND DRESSING
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Date Cleared
    2006-09-21

    (113 days)

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

    PEGASUS BIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pegasus Biologics DermADAPT™ Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: - Partial and full thickness wounds, . - . Draining wounds, - Pressure sores/ulcers, ● - Venous ulcers, . - Chronic vascular ulcers, . - Diabetic ulcers, . - Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), . - Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)
    Device Description
    The Pegasus Biologics DermADAPT™ Wound Dressing is a decellularized, equine pericardial implant that has been crosslinked and passed USP Sterility testing. The product is non-pyrogenic and supplied for single use only. The product must be rinsed prior to use following the procedure described in the IFU.
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    K Number
    K043388
    Device Name
    PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Date Cleared
    2005-08-05

    (239 days)

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

    PEGASUS BIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar. Achilles, biceps, quadriceps, or other tendons. OrthADAPT® 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. OrthADAPT® is intended for one-time use only.
    Device Description
    The OrthADAPT Bioimplant is a decellularized equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterillant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
    Ask a Question

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