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

    aprevo® Digital Workflow

    K Number: K222195 · Decision Dec 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    14
    Review Days
    161

    Basic Information

    Device Name
    aprevo® Digital Workflow
    K Number
    K222195
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carlsmed, Inc.
    Date Received
    July 22, 2022
    Decision Date
    December 30, 2022
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by Carlsmed, Inc.

    K Number Device Name
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    K242599 aprevo® Digital Planning
    K243635 aprevo® anterior lumbar interbody fusion device with interfixation
    K241477 aprevo® anterior lumbar interbody fusion device with interfixation
    K241332 aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device
    K232282 aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
    K231955 aprevo® Digital Segmentation
    K231140 aprevo® transforaminal lumbar interbody fusion device
    K222009 aprevo® anterior lumbar interbody fusion device with interfixation
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