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510(k) Data Aggregation

    K Number
    K163011
    Device Name
    PHA S1 Spinal System
    Manufacturer
    Phamedica, Inc.
    Date Cleared
    2017-06-29

    (244 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Phamedica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/ Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or all of the following indications: · Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e., fracture or dislocation) - · Spinal Stenosis - · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - · Failed previous fusion in skeletally mature patients.
    Device Description
    Phamedica PHA S1 Spinal Fixation system consists of Poly Axial screws, Mono Axial Screws, Poly Axial and Mono Axial Reduction Screws, Rods, Set Screws, Transverse and Offset connectors made from Titanium Alloy Ti6AL4V which can be variously assembled for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.
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