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510(k) Data Aggregation

    K Number
    K111838
    Device Name
    INQU PASTE MIX
    Manufacturer
    ISTO TECHNOLOGIES, INC.
    Date Cleared
    2011-09-26

    (89 days)

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

    ISTO TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created osseous defects, or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    InQu Paste Mix is intended for single patient use only. The device is a sterile, granular, synthetic bone void filler composed of poly (D,L-lactide-co-glycolide) and hyaluronic acid. InQu is combined with a fluid (e.g. saline or blood) to form a paste, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.
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    K Number
    K103799
    Device Name
    INQU PASTE MIX PLUS
    Manufacturer
    ISTO TECHNOLOGIES, INC.
    Date Cleared
    2011-08-29

    (244 days)

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

    ISTO TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InQu® is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu® is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis) and as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    InQu® Paste Mix Plus is intended for single patient use only. The device is a sterile, granular, synthetic bone void filler composed of poly (D,L-lactide-co-glycolide), hyaluronic acid and sodium carboxymethylcellulose provided in powder form, added to improve handling characteristics. The two components are mixed at the time of use and combined with a fluid (e.g. saline or blood) to form a putty, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.
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    K Number
    K071428
    Device Name
    INQU
    Manufacturer
    ISTO TECHNOLOGIES, INC.
    Date Cleared
    2007-09-17

    (117 days)

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

    ISTO TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
    Device Description
    InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process.
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    K Number
    K063359
    Device Name
    INQU
    Manufacturer
    ISTO TECHNOLOGIES, INC.
    Date Cleared
    2007-04-16

    (160 days)

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

    ISTO TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended to be gently packed into bony gaps or voids in the skeletal system (extremities and pelvis). These defects may be surgically created or result from traumatic injury to the bone.
    Device Description
    InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process. Testing has confirmed InQu™ is biocompatible as a bone void filler device. InQu™ is substantially equivalent to the predicate device in terms of material composition. technological characteristics and bone healing performance in an animal model.
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