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510(k) Data Aggregation

    K Number
    K130461
    Device Name
    STALIF X
    Manufacturer
    CENTINEL SPINE INC.
    Date Cleared
    2013-08-28

    (187 days)

    Product Code
    OVD
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENTINEL SPINE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STALIF X™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels: DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF X™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine. The STALIF X™ system should be used with bone grafting material (autograft only).
    Device Description
    The STALIF XTM is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used with supplemental fixation. The device is manufactured from PEEK Optima LT-1 or Zeniva ZA PEEK per ASTM F2026 and titanium alloy (Ti6Al4V) per ASTM F136.
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