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

    SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X

    K Number: K020085 · Decision Dec 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    10
    Review Days
    334

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
    K Number
    K020085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sintea Biotech, Inc.
    Date Received
    January 10, 2002
    Decision Date
    December 10, 2002
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MNH), ordered by most recent decision date.

    Reliance Spinal Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CastleLoc Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FixxSure® X-Link

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spinal fixation system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANAX™ 5.5 Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Sintea Biotech, Inc.

    K Number Device Name
    K082679 LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
    K081631 SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
    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
    K022065 SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X