BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Expandable Titanium PLIF/TLIF System

    K Number: K201024 · Decision Apr 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422
    Same Product Code
    869
    Applicant Total
    2
    Review Days
    374

    Basic Information

    Device Name
    Expandable Titanium PLIF/TLIF System
    K Number
    K201024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Spine, LLC
    Date Received
    April 20, 2020
    Decision Date
    April 29, 2021
    Product Code
    MAX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.

    PathLoc Lumbar Interbody Fusion Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® posterior/transforaminal lumbar interbody fusion device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Testa TP Pivoting Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    X-PAC® LLIF Expandable Lateral Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Spectrum Spine, LLC

    K Number Device Name
    K173518 Spectrum Spine Expandable Cages (SSEC)