BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    KEYSTONE PEEK Cage System

    K Number: K211689 · Decision Sep 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    9
    Review Days
    111

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    Basic Information

    Device Name
    KEYSTONE PEEK Cage System
    K Number
    K211689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Sanyou Medical Co, Ltd.
    Date Received
    June 2, 2021
    Decision Date
    September 21, 2021
    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 Shanghai Sanyou Medical Co, Ltd.

    K Number Device Name
    K230872 Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System
    K230961 Zeus Spinal System
    K231931 Adena-Zina Spinal System
    K212066 Adena-Zina System
    K163366 Shanghai Sanyou CARMEN Cervical Fusion System
    K163422 Shanghai Sanyou PEEK Cage System
    K152781 Adena-Zina System
    K131512 KATIA SYSTEM