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

    SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System

    K Number: K180665 · Decision Nov 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    8
    Review Days
    259

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
    K Number
    K180665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    K2m, LLC
    Date Received
    March 14, 2018
    Decision Date
    November 28, 2018
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

    Similar 510(k) Clearances

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

    VyBrate™ VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vertiwedge® Intraosseous System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KONG®-TL VBR System and KONG® C VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DOMINION Expandable Corpectomy System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VerteLoc Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ascend VBR System, Ascend NanoTec VBR System

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

    Other Clearances by K2m, LLC

    K Number Device Name
    K140529 EVEREST SPINAL SYSTEM
    K052404 DENALI DEFORMITY SYSTEM
    K060442 PYRENEES CERVICAL PLATE SYSTEM
    K052398 MESA SPINAL SYSTEM
    K051531 TECTONIC CERVICAL PLATE SYSTEM
    K051454 ALEUTIAN SPACER SYSTEM
    K042635 DENALI SPINE SYSTEM