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

    PMT Posterior Fixation System

    K Number: K172279 · Decision Sep 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    21
    Review Days
    54

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    Basic Information

    Device Name
    PMT Posterior Fixation System
    K Number
    K172279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Providence Medical Technology, Inc.
    Date Received
    July 28, 2017
    Decision Date
    September 20, 2017
    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 Providence Medical Technology, Inc.

    K Number Device Name
    K261665 CORUS™ Navigation System-GN
    K253676 CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
    K253190 CORUS-LX Implant
    K251060 CORUS™ Navigation System-GX
    K251885 CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
    K241035 PMT Posterior Cervical Stabilization System (PCSS)
    K240625 CORUS Navigation Access System
    K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)
    K230297 PMT Expandable Cage (PMT EXP)
    K220951 PMT Facet Fixation System (PMT FFS)
    Search all 21 clearances from Providence Medical Technology, Inc. →