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

    OSTEOMED INTRAORAL DISTRACTION SYSTEM

    K Number: K990944 · Decision Jun 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    59
    Applicant Total
    27
    Review Days
    86

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    Basic Information

    Device Name
    OSTEOMED INTRAORAL DISTRACTION SYSTEM
    K Number
    K990944
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomed Corp.
    Date Received
    March 22, 1999
    Decision Date
    June 16, 1999
    Product Code
    MQN
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQN External Mandibular Fixator And/Or Distractor

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    Other Clearances by Osteomed Corp.

    K Number Device Name
    K151021 OsteoMed Cannulated Screw System
    K022277 OSTEOMED CRANIAL FLAP FIXATION SYSTEM
    K022887 INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
    K022886 METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
    K023260 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
    K013618 INTRAORAL MANDIBULAR DISTRACTION SYSTEM
    K021618 OSA RIGID INTERNAL FIXATION SYSTEM
    K012486 OSTEOMED BIORESORBABLE FIXATION SYSTEM
    K010964 AUTO-DRIVE LAG SCREW SYSTEM
    K010783 2.0/2.4 CANNULATED SCREW SYSTEM
    Search all 27 clearances from Osteomed Corp. →