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

    RESORABPLUG

    K Number: K920118 · Decision Feb 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    36
    Applicant Total
    23
    Review Days
    392

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    Basic Information

    Device Name
    RESORABPLUG
    K Number
    K920118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sofamor Danek Mfg., Inc.
    Date Received
    January 13, 1992
    Decision Date
    February 8, 1993
    Product Code
    LZN
    Advisory Committee
    General, Plastic Surgery
    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
    LZN Cement Obturator

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    Other Clearances by Sofamor Danek Mfg., Inc.

    K Number Device Name
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    K930191 DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
    K932029 TSRH SPINAL SCREWS
    K922486 DANEK TISSUE CUTTING AND REMOVAL SYSTEM
    K930807 SENTRY ANTERIOR SPINAL SYSTEM
    K930710 SENTRY POSTERIOR SPINAL SYSTEM
    K923242 CROSSLINK AXIAL AND OFFSET PLATES
    K922543 Z-PLATE ANTERIOR FIXATION SYSTEM
    K922672 AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
    K925811 TSRH CENTRAL POST HOOKS
    Search all 23 clearances from Sofamor Danek Mfg., Inc. →