Kyphon Inc

4 dispositivos en la base de datos

  • Modelo / Serial
    Lot code J8052810
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Nationwide Distribution.
  • Descripción del producto
    KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).
  • Modelo / Serial
    All units of the Catalog Numbers.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA, UK, Netherlands, Canada, Australia, Denmark, Germany, Greece, Hong Kong, Israel, Italy, Philippines, Portugal, Singapore, South Africa, Spain Switzerland, Turkey and UAE.
  • Descripción del producto
    X-STOP Interspinous Process Decompression (lPD) System, || (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); || Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP. || Catalog numbers include for X-STOP PEEK Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk, 1-3210 US 10mm X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk, 1-3216 US 16mm X STOPpk. || Product is manufactured and distributed by Medtronic Spine LLC (formerly Kyphon Inc.); || Spinal implants.
  • Modelo / Serial
    Lot Number : J6033011 and Lot Number : J6013101
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.
  • Descripción del producto
    Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089
  • Modelo / Serial
    Lot Numbers: J6033012 and J6013102
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.
  • Descripción del producto
    Functional Anaesthetic Discography (F.A.D.) Catheter || System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089

3 fabricantes con un nombre similar

Más información acerca de la data acá

  • Dirección del fabricante
    Medtronic Spine LLC, formerly Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • 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 Spine LLC (formerly Kyphon Inc.), 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • 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
    Kyphon Inc, 1350 Bordeaux Dr, Sunnyvale CA 94089-1005
  • Source
    USFDA