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

    SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X

    K Number: K043355 · Decision Dec 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    11

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    Basic Information

    Device Name
    SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
    K Number
    K043355
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sintea Biotech, Inc.
    Date Received
    December 6, 2004
    Decision Date
    December 17, 2004
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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    Other Clearances by Sintea Biotech, Inc.

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    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
    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