BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SECURE-LOCK

    K Number: K220906 · Decision Jul 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    283
    Registration Numbers
    283
    Same Product Code
    203
    Applicant Total
    9
    Review Days
    115

    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
    SECURE-LOCK
    K Number
    K220906
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xiros, Ltd.
    Date Received
    March 29, 2022
    Decision Date
    July 22, 2022
    Product Code
    HTY
    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
    HTY Pin, Fixation, Smooth

    Similar 510(k) Clearances

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

    ZipToe™ Hammertoe Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Impact PEEK Union Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RONAVIS – FX (FX-001)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PediFlex™ Flexible Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Impact PEEK Union Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Biomet Kirschner Wires (K-Wires)

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

    Other Clearances by Xiros, Ltd.

    K Number Device Name
    K230671 Pitch PaSoft Tissue Reinforcement Device
    K222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
    K220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
    K211563 Pitch-Patchs
    K191053 Xtreme-Loop
    K180243 Infinity-Lock Button System
    K171680 Infinity-Lock 3, Infinity-Lock 5
    K151601 SECURE-LOOP