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

    BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE

    K Number: K925098 · Decision Jul 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    283
    Registration Numbers
    283
    Same Product Code
    203
    Applicant Total
    4
    Review Days
    649

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    Basic Information

    Device Name
    BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE
    K Number
    K925098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Bioscience, Inc.
    Date Received
    October 8, 1992
    Decision Date
    July 19, 1994
    Product Code
    HTY
    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
    HTY Pin, Fixation, Smooth

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    Other Clearances by Bioscience, Inc.

    K Number Device Name
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    K955003 BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK
    K952471 BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD