Devices

MultiAxial Screw

  • Modèle / numéro de série
    Catalog Number 6588, Packaging Lot: 651150, Unpackaged lot 605119
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.
  • Description du dispositif
    Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; || Biomet Spine, Parsippany, NJ 07054 || The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.
  • Manufacturer
    EBI, L.P.
  • 1 Event

Fabricant

EBI, L.P.
  • Adresse du fabricant
    EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall MULTIAXIAL SCREW
  • Modèle / numéro de série
    Lot Numbers: 0132008W, 0150703W, 0150705W, and 0166823W
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
  • Description du dispositif
    CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 || implantation
  • Manufacturer
    Medtronic Sofamor Danek USA Inc
Device Recall MULTIAXIAL SCREW
  • Modèle / numéro de série
    Lot Numbers: 0154947W and 0163314W
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
  • Description du dispositif
    CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 || implantation
  • Manufacturer
    Medtronic Sofamor Danek USA Inc