BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM

    K Number: K102204 · Decision Nov 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    22
    Review Days
    102

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    Basic Information

    Device Name
    CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
    K Number
    K102204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choicespine, LP
    Date Received
    August 5, 2010
    Decision Date
    November 15, 2010
    Product Code
    NKB
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Choicespine, LP

    K Number Device Name
    K190227 Boomerang™ Anterior Cervical Plate System
    K183397 ChoiceSpine Stealth Cervical Spacer System
    K182721 Choice Spine Navigation System
    K183214 Raven Lumbar Plate System
    K180519 HARRIER-SA™ Lumbar Interbody System
    K172816 TiGer Shark™ System
    K173215 Choice Spine Laminoplasty™ Fixation System
    K171489 Acapella Cervical Spacer System
    K170821 ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
    K170942 The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
    Search all 22 clearances from Choicespine, LP →