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

    Endoskeleton TO Interbody Fusion Device (IBD)

    K Number: K170399 · Decision Jul 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    14
    Review Days
    147

    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
    Endoskeleton TO Interbody Fusion Device (IBD)
    K Number
    K170399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Titan Spine, LLC
    Date Received
    February 9, 2017
    Decision Date
    July 6, 2017
    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 Titan Spine, LLC

    K Number Device Name
    K173535 Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
    K163269 Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device
    K153122 Endoskeleton(r) TCS System
    K151596 Endoskeleton TCS Interbody Fusion Device
    K142940 Endoskeleton TCS System
    K141953 ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
    K142589 Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL
    K140055 ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
    K111626 ENDOSKELETON(R) TAS
    K102067 ENDOSKELETON TO
    Search all 14 clearances from Titan Spine, LLC →