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

    PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM

    K Number: K974203 · Decision Feb 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
    K Number
    K974203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integrated Orbital Implants, Inc.
    Date Received
    November 10, 1997
    Decision Date
    February 4, 1998
    Product Code
    MQU
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQU Ocular Peg

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    Other Clearances by Integrated Orbital Implants, Inc.

    K Number Device Name
    K003338 BIO-EYE II ORBITAL IMPLANT
    K000151 PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
    K982562 BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
    K891137 MOTILITY ORBITAL IMPLANT