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

    Captiva Spine FuselOX Cervical IBF System

    K Number: K142586 · Decision May 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    7
    Review Days
    255

    Basic Information

    Device Name
    Captiva Spine FuselOX Cervical IBF System
    K Number
    K142586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Captiva Spine
    Date Received
    September 15, 2014
    Decision Date
    May 28, 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

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    Other Clearances by Captiva Spine

    K Number Device Name
    K160020 Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
    K151116 CapLOX II/TowerLOX Pedicle Screw System
    K141332 Captiva Spine SmartLOX Cervical Plate System
    K131538 CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
    K122956 FUSELOX LUMBAR INTERBODY FUSION DEVICE
    K122332 TOWERLOX PEDICLE SCREW SYSTEM