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

    SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X

    K Number: K031154 · Decision Jun 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    93
    Applicant Total
    10
    Review Days
    74

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    Basic Information

    Device Name
    SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
    K Number
    K031154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sintea Biotech, Inc.
    Date Received
    April 11, 2003
    Decision Date
    June 24, 2003
    Product Code
    JDW
    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
    JDW Pin, Fixation, Threaded

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    K043355 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
    K041989 SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
    K020085 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
    K022065 SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X