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510(k) Data Aggregation

    K Number
    K243302
    Device Name
    3DMatrix DynaFlex (DynaFlex)
    Manufacturer
    PrintBio, Inc.
    Date Cleared
    2025-05-21

    (215 days)

    Product Code
    OXF, OWT, OWZ, OXC
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PrintBio, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3DMatrix DynaFlex (DynaFlex) is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where DynaFlex may be used include: - Suture line reinforcement including for hernia repair - Muscle flap reinforcement - General tissue reconstructions
    Device Description
    3DMatrix DynaFlex ("DynaFlex") is a single-use, fully absorbable, colorless, non-woven, 3D-printed, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). DynaFlex is provided in three sizes, 6 cm x 5.5 cm, 6 cm x 14.5 cm, and 5 cm x 17 cm, that can be cut to the desired shape and size for each specific application at the time of use. DynaFlex is terminally sterilized by Ethylene Oxide validated to an SAL of 10-6 and intended to be used by prescription only in a healthcare facility or hospital. Once implanted, DynaFlex acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. DynaFlex provides temporary mechanical support and stabilization during the healing process. DynaFlex mesh is not isotropic so the mechanical properties of DynaFlex mesh are direction dependent.
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    K Number
    K232602
    Device Name
    3DMatrix Surgical Mesh
    Manufacturer
    PrintBio, Inc.
    Date Cleared
    2024-05-23

    (269 days)

    Product Code
    OXF, OWT, OWZ, OXC
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PrintBio, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3DMatrix is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where 3DMatrix may be used include: - Suture line reinforcement including for hernia repair - Muscle flap reinforcement - General tissue reconstructions
    Device Description
    3DMatrix Surgical Mesh (3DMatrix) is a single-use, fully absorbable, colorless, non-woven, 3Dprinted, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). 3DMatrix is provided in two sizes, 60 mm x 55 mm and 60 mm x 145 mm that can be cut to the desired shape and size for each specific application at the time of use. 3DMatrix is terminally sterilized by Ethylene Oxide validated to an SAL of 10- and intended to be used by prescription only in a healthcare facility or hospital. 3DMatrix is a medical device used for surgical repair or reinforcement of soft tissue. Once implanted, 3DMatrix acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. 3DMatrix provides temporary mechanical support and stabilization during the healing process.
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