BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇺🇸 United States

    OSTEOMED GREAT TOE SYSTEM

    K Number: K922211 · Decision Nov 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    27
    Review Days
    546

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    Basic Information

    Device Name
    OSTEOMED GREAT TOE SYSTEM
    K Number
    K922211
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Osteomed Corp.
    Date Received
    May 12, 1992
    Decision Date
    November 9, 1993
    Product Code
    LZJ
    Advisory Committee
    Unknown
    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
    LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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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. →