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

    Synapse Occipital-Cervical-Thoracic (OCT) System

    K Number: K142838 · Decision Jan 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    16
    Review Days
    112

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    Basic Information

    Device Name
    Synapse Occipital-Cervical-Thoracic (OCT) System
    K Number
    K142838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA Products, LLC
    Date Received
    September 30, 2014
    Decision Date
    January 20, 2015
    Product Code
    NKG
    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
    NKG Posterior Cervical Screw System

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    Other Clearances by Synthes USA Products, LLC

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    K162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
    K151276 DePuy Synthes T-PAL Ti Spacer
    K143285 Mandible External Fixator - MR Conditional
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