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

    NEXA BONE PLATE AND SCREW SYSTEM

    K Number: K053408 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    16
    Review Days
    15

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    Basic Information

    Device Name
    NEXA BONE PLATE AND SCREW SYSTEM
    K Number
    K053408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexa Orthopedics, Inc.
    Date Received
    December 7, 2005
    Decision Date
    December 22, 2005
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Nexa Orthopedics, Inc.

    K Number Device Name
    K072710 NEXFIX COMPRESSION PIN
    K071147 NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
    K070688 NEXFIX COMPRESSION STAPLE
    K060386 NEXA CARPO METACARPAL IMPLANT
    K060071 NEXA COMPRESSION SCREW
    K053394 NEXA BONE SCREW SYSTEM
    K051740 TAPERED COMPRESSION PIN
    K051406 OSTEOCURE RESORBABLE BEAD KIT
    K033046 SUBTALAR PEG IMPLANT
    K032902 SUBTALAR ARTHRORISIS IMPLANT
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