BEUDAMED
    Product Code: OJB FDA class 2 21 CFR 888.3060

    Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

    Orthopedic

    The Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate is a resorbable plate implant used during spinal fusion procedures to maintain the relative position of weak bony tissue such as allografts or autografts, working in conjunction with traditional rigid fixation systems until the bone graft consolidates. Classified as FDA Class 2 under regulation 21 CFR 888.3060 within the Orthopedic medical specialty, it requires a 510(k) premarket notification. The product code is OJB. It is flagged as an implant device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    10

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    Basic Information

    Product Code
    OJB
    Device Class
    FDA class 2
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K151360 Inion Spinal Graft Containment System
    K071810 INION SPINAL GRAFT CONTAINMENT SYSTEM
    K051821 INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.