Biomet U.K., Ltd.

25 dispositifs dans la base de données

  • Modèle / numéro de série
    32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.
  • Description du dispositif
    REF 32-422760 || Oxford Uni Knee System,Toffee Hammer, non-sterile, || found in REF 32-422763 Oxford Mlcroplasty Knee System || Tibial instrument Tray || small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
  • Modèle / numéro de série
    Item:32-420056, Lots: ZB160701
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
  • Description du dispositif
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B || Product Usage: || Instruments for use with the Oxford Uni Partial Knee System
  • Modèle / numéro de série
    Item:32-420057, Lots: ZB160701
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
  • Description du dispositif
    Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B || Product Usage: || Instruments for use with the Oxford Uni Partial Knee System
  • Modèle / numéro de série
    Item:32-420058, Lots: ZB160701
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
  • Description du dispositif
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C || Product Usage: || Instruments for use with the Oxford Uni Partial Knee System
  • Modèle / numéro de série
    Item:32-420059, Lots: ZB160701
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
  • Description du dispositif
    Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C || Product Usage: || Instruments for use with the Oxford Uni Partial Knee System
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  • Adresse du fabricant
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend, South Wales United Kingdom
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA