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

    Reliance Lumbar IBF System

    K Number: K173283 · Decision Jan 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    24
    Review Days
    95

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Reliance Lumbar IBF System
    K Number
    K173283
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reliance Medical Systems, LLC
    Date Received
    October 16, 2017
    Decision Date
    January 19, 2018
    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.

    Fule Interbody Fusion Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exceed® Biplanar Expandable Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BMD Titanium Spinal Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ventana® P/T Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VersaLift Expandable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system

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

    Other Clearances by Reliance Medical Systems, LLC

    K Number Device Name
    K202266 Reliance Cervical IBF System
    K210874 Reliance Spinal Screw System
    K183049 Reliance Lumbar IBF System
    K173102 Reliance Cervical IBF System
    K172489 Reliance Cervical IBF System
    K162066 Reliance Spinal Screw System
    K160463 Reliance Lumbar IBF System
    K152131 Reliance Spinal Screw System
    K142269 Reliance Cervical IBF System
    K142867 Reliance Posterior Cervical-Thoracic System
    Search all 24 clearances from Reliance Medical Systems, LLC →