BEUDAMED
    Product Code: PML FDA class 2 21 CFR 888.3027

    Bone Cement, Posterior Screw Augmentation

    Orthopedic

    The Bone Cement, Posterior Screw Augmentation (product code PML) is a Class 2 orthopedic device intended to augment the fixation of screws in a posterior spinal system construct, regulated under 888.3027. It requires 510(k) clearance and is flagged as an implant device, as it is used internally at the site of spinal screw fixation. The device is not life-sustaining.

    View on FDA
    510(k)s
    19
    FEI Numbers
    80
    Registration Numbers
    80
    Unique Applicants
    16
    Years Active
    10

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    Basic Information

    Product Code
    PML
    Device Class
    FDA class 2
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device is intended to augment the fixation of screws in a posterior spinal system construct.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 19 510(k) clearances via K numbers.

    K Number Device Name
    K260286 Dynamo™ Spinal Cement; Salvo® Spine System
    K252885 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
    K241034 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
    K231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
    K230774 PERLA® TL System; TEKTONA® HV US Bone Cement
    K222789 VADER® Pedicle System, G21 Cement
    K221926 Invictus® Bone Cement, Invictus Spinal Fixation System
    K222256 BonOs® Inject Bone Cement; NEO Pedicle Screw System™
    K212489 BonOs Inject Bone Cement; NEO Pedicle Screw System
    K200596 G21 Cement, VADER® Pedicle System
    K201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement
    K192818 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
    K190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
    K191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
    K180498 NuVasive Reline Fenestrated Screws, High V+ Bone Cement
    K172269 FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
    K171938 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
    K160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems
    K152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

    FEI Numbers

    This FDA classification entry is associated with 80 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.