Omnilife Science Inc.

4 dispositifs dans la base de données

  • Modèle / numéro de série
    Lot: 17284
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US: CA, OK, VA, FL, MA, NY, TX
  • Description du dispositif
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
  • Modèle / numéro de série
    Lot Numbers: MM0314R, VA0713, Z1111
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
  • Description du dispositif
    Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 || Product Usage: || The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. || Product Usage: || The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
  • Modèle / numéro de série
    H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
  • Description du dispositif
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. || Product Usage: || The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
  • Modèle / numéro de série
    Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
  • Description du dispositif
    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA || Product Usage: || The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

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  • Adresse du fabricant
    OMNIlife science Inc., 480 Paramount Dr, Raynham MA 02767-1085
  • Société-mère du fabricant (2017)
  • Source
    USFDA