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

    Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices

    K Number: K150788 · Decision Oct 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    10
    Review Days
    203

    Basic Information

    Device Name
    Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices
    K Number
    K150788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meditech Spine, LLC
    Date Received
    March 25, 2015
    Decision Date
    October 14, 2015
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    Similar 510(k) Clearances

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

    BluEX Cervical Expandable Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTEOMNI SPINAL CAGES SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORIO-3D Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOD-C

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

    Other Clearances by Meditech Spine, LLC

    K Number Device Name
    K210286 Cure 2.0 Anterior Cervical Plate (ACP) System
    K201506 Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
    K201136 Cure™ Lumbar Plate System
    K181543 Cure™ OPEL-C Plate System
    K180090 Cure™ Lumbar Plate System
    K171538 Cure™ Lumbar Plate System
    K170395 Talos® Lumbar (HA) PEEK IBF Devices
    K160604 Cure™ Anterior Cervical Plate (ACP) System
    K142345 Talos-C(HA) Cervical Intervertebral Body Fusion Devices