BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    BEE Cervical Cage

    K Number: K231371 · Decision Jan 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    7
    Review Days
    245

    Basic Information

    Device Name
    BEE Cervical Cage
    K Number
    K231371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NGMedical GmbH
    Date Received
    May 12, 2023
    Decision Date
    January 12, 2024
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    Similar 510(k) Clearances

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

    BluEX Cervical Expandable Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTEOMNI SPINAL CAGES SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORIO-3D Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOD-C

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

    Other Clearances by NGMedical GmbH

    K Number Device Name
    K261067 BEE PLIF Cage
    K250560 BEE HA
    K212050 NGM WAVE PLIF Cage
    K211413 BEE PLIF Cage
    K203444 BEE HA Cage
    K200429 BEE Cages