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510(k) Data Aggregation

    K Number
    K253266

    Validate with FDA (Live)

    Device Name
    Titanium Interbody System
    Manufacturer
    Spine Innovation, LLC
    Date Cleared
    2026-01-08

    (101 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K153356
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Titanium Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Titanium Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Titanium Interbody System.

    Device Description

    The Titanium Interbody System is an expandable interbody fusion device and corresponding instruments intended to stabilize a spinal segment to promote fusion. The implant is sold sterile and is available in various sizes to accommodate varying patient anatomy.

    AI/ML Overview

    N/A

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