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

    PROCOTYL® PRIME E-CLASS™ XLPE Liner

    K Number: K171181 · Decision Aug 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    284
    Registration Numbers
    284
    Same Product Code
    522
    Applicant Total
    6
    Review Days
    126

    Basic Information

    Device Name
    PROCOTYL® PRIME E-CLASS™ XLPE Liner
    K Number
    K171181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MicroPort Orthopedics, Inc.
    Date Received
    April 24, 2017
    Decision Date
    August 28, 2017
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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    Other Clearances by MicroPort Orthopedics, Inc.

    K Number Device Name
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    K180317 EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
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    K162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions