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

    OSTEOMNI SPINAL FIXATION SYSTEM

    K Number: K254247 · Decision Feb 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    2
    Review Days
    57

    Basic Information

    Device Name
    OSTEOMNI SPINAL FIXATION SYSTEM
    K Number
    K254247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomni, Inc.
    Date Received
    December 29, 2025
    Decision Date
    February 24, 2026
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Osteomni, Inc.

    K Number Device Name
    K260850 OSTEOMNI SPINAL CAGES SYSTEM