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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    STERN FIX Sternal Stabilization System

    K Number: K221795 · Decision Oct 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    6
    Review Days
    120

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    Basic Information

    Device Name
    STERN FIX Sternal Stabilization System
    K Number
    K221795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neos Surgery S.L
    Date Received
    June 21, 2022
    Decision Date
    October 19, 2022
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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    Other Clearances by Neos Surgery S.L

    K Number Device Name
    K240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
    K211613 Stern Fix Sternal Stabilization System
    K160739 Cranial COVER
    K132044 CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
    K101235 CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM