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510(k) Data Aggregation

    K Number
    K254182

    Validate with FDA (Live)

    Device Name
    Aster
    Manufacturer
    Osteonic Co., Ltd.
    Date Cleared
    2026-02-26

    (65 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K212139,K230546
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ASTER 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 ASTER is an anterior cervical plate system made from titanium alloy in accordance with ASTM F136. The system consists of various plates and screws, and fixation is achieved by inserting bone screws through the plate openings into the cervical vertebral bodies. Each plate includes locking caps designed to prevent screw back-out, and the locking caps are provided pre-assembled to the plate.

    A variety of plate lengths and screw configurations are available to accommodate patient anatomy. The product is supplied only in a non-sterile condition, and must be steam sterilized prior to use.

    AI/ML Overview

    N/A

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