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

    ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS

    K Number: K073233 · Decision Jan 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    74

    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
    ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
    K Number
    K073233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3590
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Bio-Surfaces, Inc.
    Date Received
    November 15, 2007
    Decision Date
    January 28, 2008
    Product Code
    HSH
    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
    HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

    Similar 510(k) Clearances

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

    ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OTI UNICONDULAR INTERPOSITIONAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNICONDYLAR INTERPOSITIONAL SPACER

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

    Other Clearances by Advanced Bio-Surfaces, Inc.

    K Number Device Name
    K053094 ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056