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

    Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

    K Number: K222978 · Decision Dec 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    90

    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
    Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
    K Number
    K222978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xiros, Ltd.
    Date Received
    September 28, 2022
    Decision Date
    December 27, 2022
    Product Code
    QUW
    Advisory Committee
    General, Plastic Surgery
    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
    QUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

    Similar 510(k) Clearances

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

    TekBrace Solo Soft Tissue Reinforcement Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Jewel Soft Tissue Reinforcement Device (102-6005)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TekBrace Solo Soft Tissue Reinforcement Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Xiros, Ltd.

    K Number Device Name
    K230671 Pitch PaSoft Tissue Reinforcement Device
    K220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
    K220906 SECURE-LOCK
    K211563 Pitch-Patchs
    K191053 Xtreme-Loop
    K180243 Infinity-Lock Button System
    K171680 Infinity-Lock 3, Infinity-Lock 5
    K151601 SECURE-LOOP