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510(k) Data Aggregation

    K Number
    K253250

    Validate with FDA (Live)

    Date Cleared
    2025-12-01

    (63 days)

    Product Code
    Regulation Number
    888.3050
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spinal Simplicity Minuteman G6 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (L1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

    • Lumbar spinal stenosis;
    • Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
    • Spondylolisthesis.

    The Minuteman G6 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

    Device Description

    The Minuteman G6 MIS Fusion Plate is a minimally invasive, interspinous-interlaminar fusion device intended for the fixation and fusion of the lumbar and sacral spine. The Minuteman G6 MIS Fusion Plate is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is coated with hydroxyapatite (HA) per ASTM F1185. It is designed for attachment to the posterior non-cervical spine at the spinous processes through its two sets of wings and is intended for use with bone graft material placed within the device. The Minuteman G6 MIS Fusion Plate provides immobilization, stabilization, and fusion across the spinal segments. The core threaded post provides controlled distraction, while a wide range of sizes allows for enhanced anatomical fit. The Minuteman G6 MIS Fusion Plate can easily be placed under fluoroscopy through a lateral transverse MIS approach. The Minuteman G6 MIS Fusion Plate is delivered sterile and individually packed.

    AI/ML Overview

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