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

    CapLOX II®/TowerLOX® MIS Pedicle Screw System

    K Number: K193270 · Decision Jan 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    8
    Review Days
    66

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    Basic Information

    Device Name
    CapLOX II®/TowerLOX® MIS Pedicle Screw System
    K Number
    K193270
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Captiva Spine, Inc.
    Date Received
    November 26, 2019
    Decision Date
    January 31, 2020
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Captiva Spine, Inc.

    K Number Device Name
    K181229 TirboLOX-C Cervical IBFD
    K180990 TirboLOX-L Lumbar IBFD
    K180475 CapLOX II® / TowerLOX® MIS Pedicle Screw System
    K120292 CAPLOX II PEDICLE SCREW SYSTEM
    K111115 CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
    K110585 CAPTIVA SPINE FUSELOX CERVICAL CAGE
    K092017 PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)