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510(k) Data Aggregation

    K Number
    K960988
    Device Name
    LACTOSORB TRAUMA PLATING SYSTEM
    Manufacturer
    POLY-MEDICS,INC.
    Date Cleared
    1996-04-10

    (34 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLY-MEDICS,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. - Comminuted fractures of the naso-ethmoidal and l. infraorbital areas. - 2. Comminuted fractures of the frontal sinus wall. - 3. Trauma of the midface or craniofacial skeleton. - 4 . Reconstructive procedures of the midface or craniofacial skeleton. This system is not designed for use in the mandible and/or full load bearing procedures.
    Device Description
    The LactoSorb® implants are made of bioresorbable and biocompatible polymer that have been used in surqical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in for over 10 years in Poly humans Surqiclip® device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.
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    K Number
    K955729
    Device Name
    LACTOSORB TRAUMA PLATING SYSTEM
    Manufacturer
    POLY-MEDICS,INC.
    Date Cleared
    1996-02-14

    (58 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLY-MEDICS,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954443
    Device Name
    LACTOSORB SUTURE ANCHOR
    Manufacturer
    POLY-MEDICS,INC.
    Date Cleared
    1996-01-31

    (128 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLY-MEDICS,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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