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

    PMT Facet Fixation System, Lumbar (PMT FFS-LX)

    K Number: K230840 · Decision Dec 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    21
    Review Days
    267

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    Basic Information

    Device Name
    PMT Facet Fixation System, Lumbar (PMT FFS-LX)
    K Number
    K230840
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Providence Medical Technology, Inc.
    Date Received
    March 27, 2023
    Decision Date
    December 19, 2023
    Product Code
    MRW
    Advisory Committee
    Unknown
    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
    MRW System, Facet Screw Spinal Device

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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
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    K241035 PMT Posterior Cervical Stabilization System (PCSS)
    K240625 CORUS Navigation Access System
    K230297 PMT Expandable Cage (PMT EXP)
    K220951 PMT Facet Fixation System (PMT FFS)
    K212636 CORUS Spinal System-X
    Search all 21 clearances from Providence Medical Technology, Inc. →