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

    CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY

    K Number: K080531 · Decision Sep 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    21
    Review Days
    192

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    Basic Information

    Device Name
    CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
    K Number
    K080531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conmed Linvatec
    Date Received
    February 26, 2008
    Decision Date
    September 5, 2008
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Conmed Linvatec

    K Number Device Name
    K111779 Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
    K102410 MATRYX INTERFERENCE SCREW (5.0-6.5MM)
    K102339 CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
    K101100 CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
    K092898 CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
    K090560 CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
    K083161 ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
    K072291 CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
    K080444 CONMED LINVATEC OSPREY DRILL SYSTEM
    K073481 THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
    Search all 21 clearances from Conmed Linvatec →