BEUDAMED
    Product Code: OSH FDA class 2 21 CFR 888.3070

    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

    Orthopedic

    The Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH) is an orthopedic implant system intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft for the treatment of adolescent idiopathic scoliosis. The system uses pedicle screws and connecting rods to correct and maintain spinal alignment during the fusion process. As an FDA Class 2 device under regulation 888.3070, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    19
    FEI Numbers
    158
    Registration Numbers
    158
    Unique Applicants
    10
    Years Active
    4

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    Basic Information

    Product Code
    OSH
    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

    Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

    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
    K153446 OLYMPIC Posterior Spinal Fixation System
    K140276 CD HORIZON SPINAL SYSTEM
    K132574 PASS LP SPINAL SYSTEM
    K132303 IMPLANET SPINE SYSTEM
    K132575 PASS LP SPINAL SYSTEM
    K131802 EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
    K131615 POLARIS SPINAL SYSTEM
    K131784 RANGE SPINAL SYSTEM
    K131321 CD HORIZON SPINAL SYSTEM
    K124058 CREO STABILIZATION SYSTEM
    K131030 RANGE SPINAL SYSTEM
    K130655 RESPONSE SPINE SYSTEM
    K122877 RANGE SPINAL SYSTEM, SMALL STATURE
    K130330 RANGE SPINAL SYSTEM
    K123412 RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
    K123138 PASS LP SPINAL SYSTEM
    K121630 RANGE SPINAL SYSTEM
    K121250 OP SPINE SYSTEM
    K120291 OP SPINE SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 158 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 158 registration numbers. Click on an entry to view related FDA registrations.