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

    Fixated Asfora BULLET CAGE® (FABC)

    K Number: K181591 · Decision Sep 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    7
    Review Days
    100

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    Basic Information

    Device Name
    Fixated Asfora BULLET CAGE® (FABC)
    K Number
    K181591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Designs, LLC
    Date Received
    June 18, 2018
    Decision Date
    September 26, 2018
    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 Medical Designs, LLC

    K Number Device Name
    K182352 SP-LINK™ System
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    K112648 ASFORA BULLET CAGE
    K090048 ASFORA BULLET CAGE SYSTEM
    K042359 SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
    K002970 SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901