BEUDAMED
    Product Code: PGN FDA class 2 21 CFR 888.3070

    Growing Rod System- Magnetic Actuation

    Orthopedic

    The Growing Rod System with Magnetic Actuation is an orthopedic implant device used to stabilize or correct spinal deformities without fusion, uniquely featuring non-invasive magnetic adjustment of the spinal rod to accommodate patient growth over time. It is an FDA Class 2 device regulated under 21 CFR 888.3070, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PGN, and it is flagged as an implant. The magnetic actuation mechanism eliminates the need for repeated surgical procedures to adjust rod length.

    View on FDA
    510(k)s
    9
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    4
    Years Active
    10

    Basic Information

    Product Code
    PGN
    Device Class
    FDA class 2
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K233593 MAGEC Spinal Bracing and Distraction System
    K201543 MAGEC® System
    K171791 MAGEC® System
    K160352 MAGEC® Spinal Bracing and Distraction System
    K161751 MAGEC® Spinal Bracing and Distraction System
    K150885 MAGEC 2 Spinal Bracing and Distraction System
    K141278 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    K140613 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    K140178 ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.