BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SMR Shoulder System

    K Number: K161476 · Decision Jun 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    70
    Applicant Total
    64
    Review Days
    28

    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
    SMR Shoulder System
    K Number
    K161476
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lima Corporate S.P.A.
    Date Received
    May 27, 2016
    Decision Date
    June 24, 2016
    Product Code
    KWT
    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
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

    Similar 510(k) Clearances

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

    Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Humeral Reconstruction System Max (Tornier HRS Max)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGILON® XO Shoulder Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InSet Total Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGILON® XO Shoulder Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Comprehensive Segmental Revision System(SRS)

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

    Other Clearances by Lima Corporate S.P.A.

    K Number Device Name
    K252352 SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
    K251718 ArTT Augments and Buttresses and Bone Screws
    K243826 SMR Reverse HP Shoulder System
    K250980 Physica System (Physica CR Porous Femoral components)
    K243615 Physica Porous Femoral Components
    K234011 AMF TT Cones
    K233712 PRIMA Humeral System; PRIMA TT Glenoid
    K231099 SMR Hybrid Glenoid System
    K231925 MINIMA S System
    K221758 SMR Stemless Anatomic
    Search all 64 clearances from Lima Corporate S.P.A. →