BEUDAMED
    Product Code: NQW FDA class 2 21 CFR 888.3050

    Orthosis, Spine, Plate, Laminoplasty, Metal

    Orthopedic

    The metal laminoplasty spinal plate orthosis is an orthopedic implant that is surgically attached to the lamina following a laminoplasty or laminectomy procedure to maintain the expanded spinal canal and provide structural support to the posterior spine. It is classified as FDA Class 2 under regulation 888.3050 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag. Product code NQW is not eligible for third-party review.

    View on FDA
    510(k)s
    30
    FEI Numbers
    67
    Registration Numbers
    67
    Unique Applicants
    24
    Years Active
    22

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    Basic Information

    Product Code
    NQW
    Device Class
    FDA class 2
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 30 510(k) clearances via K numbers.

    K Number Device Name
    K252930 AQUA Laminoplasty Systems
    K243137 Curiteva Porous PEEK Laminoplasty System
    K242784 Vy Spine™ VyLam™ Laminoplasty System
    K232471 Vy Spine™ VyLam™ Laminoplasty System
    K231232 Curiteva Laminoplasty System
    K212428 Centerpiece Plate Fixation System
    K191927 Hinged Laminoplasty System
    K191169 NuVasive® Camber Laminoplasty System
    K181717 Life Spine Laminoplasty System
    K173215 Choice Spine Laminoplasty™ Fixation System
    K171413 HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
    K160114 Xspan Laminoplasty Fixation System
    K153735 Release Laminoplasty Fixation System
    K150469 Integra Laminoplasty System
    K132740 SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
    K130830 INTEGRA LAMINOPLASTY SYSTEM
    K122822 SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
    K121732 CANOPY LAMINOPLASTY FIXATION SYSTEM
    K121276 NEURO VENTION LAMINPLASTY PLATING SYSTEM
    K113802 ESCALATE LAMINOPLASTY SYSTEM
    K113218 PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
    K103284 LAMINOPLASY PLATING SYSTEM
    K100805 GALLERY LAMINOPLASTY FIXATION SYSTEM
    K091994 MOUNTAINEER LAMINOPLASTY SYSTEM
    K091623 LAMINOPLASTY FIXATION SYSTEM
    K090354 LAMINOPLASTY PLATING SYSTEM
    K080664 RELIEVE LAMINOPLASTY FIXATION SYSTEM
    K050082 CENTERPIECE PLATE FIXATION SYSTEM
    K043338 BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
    K032534 SYNTHES AFS

    FEI Numbers

    This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.