BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇩 Andorra

    KLOCKNER SURGICAL BOX

    K Number: K173642 · Decision Oct 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    11
    Review Days
    312

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    Basic Information

    Device Name
    KLOCKNER SURGICAL BOX
    K Number
    K173642
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SOADCO, S.L.
    Date Received
    November 24, 2017
    Decision Date
    October 2, 2018
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by SOADCO, S.L.

    K Number Device Name
    K243128 Klockner Kits
    K230103 Klockner Abutments
    K170022 Klockner Vega TiBase for CEREC
    K153098 KLOCKNER VEGA DENTAL IMPLANT SYSTEM
    K151194 KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
    K122988 KLOCKNER DENTAL IMPLANT ABUTMENTS
    K082200 KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
    K080224 KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
    K052654 KLOCKNER DENTAL IMPLANT, MODEL S3M
    K010132 KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
    Search all 11 clearances from SOADCO, S.L. →