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

    MOTILITY ORBITAL IMPLANT

    K Number: K891137 · Decision Aug 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    38
    Applicant Total
    5
    Review Days
    174

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MOTILITY ORBITAL IMPLANT
    K Number
    K891137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Integrated Orbital Implants, Inc.
    Date Received
    March 3, 1989
    Decision Date
    August 24, 1989
    Product Code
    HPZ
    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
    HPZ Implant, Eye Sphere

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HPZ), ordered by most recent decision date.

    EZYPOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DURETTE OCULAR IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIOCERAMIC ORBITAL IMPLANT, ORBTEX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SILICONE SPHERES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ORBITAL RECONSTRUCTIVE IMPLANT II

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EYE SPHERES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    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
    K974203 PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM