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510(k) Data Aggregation

    K Number
    K253392

    Validate with FDA (Live)

    Device Name
    Synergy Disc Instruments
    Manufacturer
    Synergy Spine Solutions, Inc.
    Date Cleared
    2026-03-27

    (178 days)

    Product Code
    QLQ
    Regulation Number
    888.4515
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K221848
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Synergy Disc Instruments are intended for the placement, positioning, and removal of the Synergy Disc.

    Device Description

    The Synergy Disc Instruments are a collection of reusable instruments designed for use with the Synergy Disc during the implantation procedure and, if necessary, device removal. Synergy Spine Solutions instruments and implants are not compatible with implants or instruments from other manufacturers unless otherwise specified. The Synergy Disc Instruments are made from various Stainless Steels (Grades 17-4, 18-8, 301, 302, 316, 465) and polymers, including High Density Polyethylene (HDPE) and medical grade Polyphenylsulfone (PPSU), as described in such standards as ASTM A564, ASTM A276, ASTM A666, ASTM F899, and ASTM D6712.

    AI/ML Overview

    N/A

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