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

    SYNTHES (USA) SPHERICAL WASHERS

    K Number: K052483 · Decision Nov 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    0
    Applicant Total
    402
    Review Days
    56

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    Basic Information

    Device Name
    SYNTHES (USA) SPHERICAL WASHERS
    K Number
    K052483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (Usa)
    Date Received
    September 9, 2005
    Decision Date
    November 4, 2005
    Product Code
    NDG
    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
    NDG Washer, Bolt, Nut, Non-Spinal, Metallic

    Other Clearances by Synthes (Usa)

    K Number Device Name
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    K111540 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
    K110789 SYNTHES STERNAL ZIPFIX SYSTEM
    K103002 SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
    K103243 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
    K102656 SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
    K093299 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
    K102694 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
    K100776 SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
    Search all 402 clearances from Synthes (Usa) →