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510(k) Data Aggregation

    K Number
    K230993
    Device Name
    CODA™ Anterior Cervical Plate System
    Manufacturer
    Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
    Date Cleared
    2023-06-20

    (75 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
    Device Description
    The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile and sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.
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    K Number
    K220244
    Device Name
    DVR® Crosslock Wrist Spanning Plate (131849181)
    Manufacturer
    Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
    Date Cleared
    2022-04-28

    (90 days)

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

    Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DVR® Crosslock Wrist Spanning Plate is indicated for skeletally mature patients for fixation of fractures, osteotomies and non-unions of the distal radius.
    Device Description
    The DVR® Crosslock Wrist Spanning Plate is a single-use plate for the fixation of fractures, osteotomies and non-unions of the distal radius. The plate spans the patient's wrist and is placed from the radial shaft to the second or third metacture pattern and patient anatomy. The plate provides ligamentotaxis on a temporary basis while the distal radius heals. The DVR® Crosslock Wrist Spanning Plate consists of a single, sterile-packed plate and is manufactured from titanium alloy (Ti-6AL-4V). The plate features hole clusters consisting of locking screw holes, a central screw cluster, and K-wire holes for preliminary fixation. There is a dorsal bend at the distal end of the plate to accommodate patient anatomy.
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