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

    OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC

    K Number: K043421 · Decision Feb 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    11
    Review Days
    65

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    Basic Information

    Device Name
    OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
    K Number
    K043421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Regeneration Technologies, Inc.
    Date Received
    December 13, 2004
    Decision Date
    February 16, 2005
    Product Code
    MQV
    Advisory Committee
    Orthopedic
    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
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by Regeneration Technologies, Inc.

    K Number Device Name
    K080418 REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
    K072238 BIOSET XCH
    K072327 CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
    K063584 STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
    K060180 BIOSET XC
    K060253 STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
    K052405 STERLING INTERFERENC SCREW HT
    K051615 STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES
    K050767 STERLING INTERFERENCE SCREW ST
    K043420 OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
    Search all 11 clearances from Regeneration Technologies, Inc. →