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

    Tomcat Cervical Spinal System

    K Number: K170953 · Decision Apr 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    150
    Applicant Total
    6
    Review Days
    21

    Basic Information

    Device Name
    Tomcat Cervical Spinal System
    K Number
    K170953
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choice Spine, LP
    Date Received
    March 31, 2017
    Decision Date
    April 21, 2017
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

    Similar 510(k) Clearances

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

    FIX-C PEEK ACIF SA System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cervical Spine Truss System (CSTS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tesera-k SC System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYLOX® ST

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Genesys Spine AIS-C II Cervical Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ProAM ACDF System

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

    Other Clearances by Choice Spine, LP

    K Number Device Name
    K183214 Raven Lumbar Plate System
    K180519 HARRIER-SA™ Lumbar Interbody System
    K173215 Choice Spine Laminoplasty™ Fixation System
    K170821 ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
    K170942 The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems