BEUDAMED
    Product Code: PLR FDA class 2 21 CFR 888.3060

    Spinal Vertebral Body Replacement Device - Cervical

    Orthopedic

    The Spinal Vertebral Body Replacement Device - Cervical (product code PLR) is a Class 2 orthopedic implant intended for vertebral body replacement in the cervical spine, regulated under 888.3060. It requires 510(k) clearance and is flagged as an implant device. The device is not classified as life-sustaining.

    View on FDA
    510(k)s
    18
    FEI Numbers
    69
    Registration Numbers
    69
    Unique Applicants
    15
    Years Active
    10

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    Basic Information

    Product Code
    PLR
    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

    Vertebral body replacement in the cervical spine.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 18 510(k) clearances via K numbers.

    K Number Device Name
    K252560 Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
    K232481 RIGEL™ 3DR Anterior Cervical Corpectomy System
    K221542 Galileo Vertebral Body Replacement Device
    K212126 MediExpand Cervical Expandable VBR System
    K211320 CAPRI Corpectomy Cage System
    K192145 Galileo Vertebral Body Replacement Device
    K193412 NEXXT MATRIXX System
    K190284 Bengal Stackable Cage System
    K190426 ALTA Anterior Cervical Corpectomy System
    K191778 Omnia Medical VBR
    K191423 Normandy VBR System
    K183071 VLIFT-s Vertebral Body Replacement System
    K180550 NuVasive Monolith Cervical Corpectomy System
    K173893 Trabis
    K180673 Normandy VBR System
    K172032 Modulift Vertebral Body Replacement (VBR) System
    K152568 C-VBR
    K151651 NuVasive X-CORE Mini Cervical Expandable VBR System

    FEI Numbers

    This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.