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

    Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System

    K Number: K153107 · Decision May 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422
    Same Product Code
    869
    Applicant Total
    10
    Review Days
    205

    Basic Information

    Device Name
    Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
    K Number
    K153107
    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
    October 27, 2015
    Decision Date
    May 19, 2016
    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

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    Other Clearances by CHOICE SPINE, LP

    K Number Device Name
    K162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
    K152515 TOMCAT Cervical Spinal System
    K140142 CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
    K133214 BLACKBIRD SPINAL SYSTEM
    K121850 Typhoon(TM) Facet Screw Fixation System
    K120570 CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
    K102204 CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
    K091926 CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
    K073669 ORIA NATURA SPACER