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510(k) Data Aggregation

    K Number
    K203282
    Device Name
    TECHFIT Patient-Specific Maxillofacial System
    Manufacturer
    Industrias Medicas Sampedro S.A.S.
    Date Cleared
    2021-05-19

    (194 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Industrias Medicas Sampedro S.A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.
    Device Description
    TECHFIT Patient-Specific Maxillofacial system is comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization. fixation, and reconstruction of the maxillofacial/midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained TECHFIT engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure that its dimensional properties allow an adequate fit. Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).
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    K Number
    K191641
    Device Name
    AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws
    Manufacturer
    Industrias Medicas Sampedro S.A.S
    Date Cleared
    2019-09-16

    (89 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Industrias Medicas Sampedro S.A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra- articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
    Device Description
    The AFFINITY - Variable Angle Distal Radius System is contains a set of titanium plates and screws that are intended to be end-user sterilized. The AFFINITY - Variable Angle Distal Radius System plates are provided in different configurations and are intended to be used in combination with the variable angle drilling guide and the Styloid hole variable angle drill guide to provide the necessary angulation for optimal screw positioning. The system includes Extra-articular plates (intermediate, wide, and narrow), Distal dorso-ulnar and dorso-radial L-plates, Distal ulnar T-plates, and straight Radius styloid plates.
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