Medtronic Sofamor Danek USA Inc

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Description

30 dispositivos en la base de datos

  • Modelo / Serial
    All Codes
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution, and the Netherlands
  • Descripción del producto
    Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON¿ LEGACY" Percutaneous Peek Spinal System
  • Modelo / Serial
    All Lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa.
  • Descripción del producto
    Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx only, MATL: TITANIUM ALLOY, Manufactured at: Warsaw, Indiana USA. || The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
  • Modelo / Serial
    A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.
  • Descripción del producto
    Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 || Orthopaedic - filler, bone void
  • Modelo / Serial
    TI13J01811
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
  • Descripción del producto
    SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. || Screwdriver - orthopedic manual surgical instrument.
  • Modelo / Serial
    Lots: M111103AAC, M111052AAT, M111059AAE, M111054AAR, M111052AAM
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.
  • Descripción del producto
    INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 || orthopaedic
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Más información acerca de la data acá

  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA
  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1719
  • Source
    USFDA
  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132-1719
  • Source
    USFDA