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

    Ascension Silicone MCP; Ascension Silicone PIP

    K Number: K233670 · Decision Dec 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    13
    Applicant Total
    22
    Review Days
    29

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    Basic Information

    Device Name
    Ascension Silicone MCP; Ascension Silicone PIP
    K Number
    K233670
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3230
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedics, Inc.
    Date Received
    November 15, 2023
    Decision Date
    December 14, 2023
    Product Code
    KYJ
    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
    KYJ Prosthesis, Finger, Constrained, Polymer

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    Other Clearances by Ascension Orthopedics, Inc.

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    K102549 THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
    K100448 ASCENSION MODULAR TOTAL SHOULDER SYSTEM
    K100502 ASCENSION TOTAL PLATE SYSTEM
    K100925 ASCENSION ANKLE FUSION NAIL SYSTEM
    K100176 ASCENSION ANKLE FUSION PLATE SYSTEM
    K092047 ASCENSION METAL GREAT TOE SYSTEM
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