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

    Tornier Humeral Nail and Tornier Long Humeral Nail

    K Number: K230352 · Decision Oct 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    295
    Registration Numbers
    295
    Same Product Code
    505
    Applicant Total
    10
    Review Days
    264

    Basic Information

    Device Name
    Tornier Humeral Nail and Tornier Long Humeral Nail
    K Number
    K230352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tornier, Inc.
    Date Received
    February 9, 2023
    Decision Date
    October 31, 2023
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by Tornier, Inc.

    K Number Device Name
    K220914 Tornier Perform Humeral System – Fracture
    K220418 Tornier Perform Humeral System – Stemless
    K211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
    K213124 Tomier Perform™ Reversed Glenoid Cannulated Glenospheres
    K201315 PERFORM Humeral System – Stem
    K191318 AEQUALIS FLEX REVIVE Shoulder System
    K183696 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
    K181420 Aequalis Flex Revive Shoulder System
    K161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid