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

    AESCULAP PEEK XP SPINAL IMPLANT SYSTEM

    K Number: K132421 · Decision Jan 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    22
    Review Days
    170

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    Basic Information

    Device Name
    AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
    K Number
    K132421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems, Inc.
    Date Received
    August 5, 2013
    Decision Date
    January 22, 2014
    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 Aesculap Implant Systems, Inc.

    K Number Device Name
    K153629 ArcadiusXP C Spinal System
    K123939 S4 SPINAL SYSTEM
    K123352 S4 SPINAL SYSTEM
    K111122 AESCULAP SIBD XP SPINAL SYSTEM
    K103284 LAMINOPLASY PLATING SYSTEM
    K100802 AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
    K092143 EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
    K083004 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
    K083311 AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
    K083495 MODIFICATION TO: METHA HIP SYSTEM
    Search all 22 clearances from Aesculap Implant Systems, Inc. →