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

    Deformity Analysis and Correction Software (DACS) and Instrumentation

    K Number: K180539 · Decision Aug 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    166

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Deformity Analysis and Correction Software (DACS) and Instrumentation
    K Number
    K180539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrowhead Medical Device Technologies, LLC
    Date Received
    February 28, 2018
    Decision Date
    August 13, 2018
    Product Code
    OSN
    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
    OSN Software For Diagnosis/Treatment

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OSN), ordered by most recent decision date.

    ENOS Software Guided External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Acute QC Strut and Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOHUB EXTERNAL FIXATOR SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Arrowhead Medical Device Technologies, LLC

    K Number Device Name
    K112675 ARROW-LOK DIGITAL SYSTEM