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510(k) Data Aggregation

    K Number
    K252611

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-22

    (126 days)

    Product Code
    Regulation Number
    888.3060
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The aprevo® cervical plating system is intended for anterior cervical fixation (C2-T1) for the following indications:

    • 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, kyphosis, and/or lordosis),
    • Tumor,
    • Pseudoarthrosis, and
    • Failed previous fusion.
    Device Description

    The aprevo® cervical plating system, which is comprised of the aprevo® cervical segmental plating system and the aprevo® cervical multilevel plating system configurations, is intended for anterior fixation of the cervical spine. The system consists of a variety of segmental and multilevel plates that are additively manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F3001 as well as a range of fixation screws manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F136. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the implants, are manufactured from stainless steel per ASTM A564. The plates, screws, and instruments are provided sterile packaged for single patient use.

    AI/ML Overview

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