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

    SINTEA BIOTECH PLS MULTI-AXIAL SCREWS

    K Number: K081631 · Decision Jul 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    10
    Review Days
    37

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    Basic Information

    Device Name
    SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
    K Number
    K081631
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sintea Biotech, Inc.
    Date Received
    June 11, 2008
    Decision Date
    July 18, 2008
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by Sintea Biotech, Inc.

    K Number Device Name
    K082679 LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
    K072198 X-VOID, SPIDER
    K070181 SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX
    K060513 SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X
    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
    K031154 SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
    K020085 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
    K022065 SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X