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

    SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION

    K Number: K132365 · Decision Aug 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    10
    Review Days
    21

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
    K Number
    K132365
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accel Spine
    Date Received
    July 30, 2013
    Decision Date
    August 20, 2013
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

    Similar 510(k) Clearances

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

    Mikron Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LumFix Spinal Fixation Sytem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Double Medical Universal Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MySpine Pedicle Screw Placement Guides - LP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier

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

    Other Clearances by Accel Spine

    K Number Device Name
    K140219 PICASSO II MIS SPINAL SYSTEM
    K131981 CEZANNE II INTERBODY FUSION SYSTEM
    K132366 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
    K121567 ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
    K121568 DALI SPINAL FIXATION SYSTEM
    K121078 VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
    K121136 RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
    K120714 PICASSO MIS SPINAL FIXATION SYSTEM
    K121569 MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM