Persona

  • Modèle / numéro de série
    Part Numbers: 42517400410, 42517400510, 42517400610, 42517400710, 42517400810, 42517400910, 42517401010, 42517401110, 42527400410, 42527400510, 42527400610, 42527400710, 42527400810, 42527400910, 42527401010, and 42527401110. Lot numbers:62043556, 62110045, 62121489, 62125589, 62147235, 62165546, 62168383, 62177247, 62311021, 62314722, 62386421, 62442838, 62525491, 62558585, 62605208, 62627292, 62683432, 62696865, 62717343, 62022344, 62041351, 62073566, 62104372, 62117744, 62121488, 62149175, 62187324, 62187325, 62247351, 62311022, 62314723, 62364961, 62391117, 62436468, 62474903, 62538403, 62564311, 62611089, 62669905, 62690895, 62720225, 62742767, 62747707, 62020946, 62028233, 62073570, 62110047, 62130976, 62187327, 62187329, 62189325, 62290822, 62305407, 62314724, 62386424, 62420258, 62469459, 62531662, 62551356, 62565041, 62584447, 62612266, 62687089, 62690049, 62690909, 62702763, 62724739, 62022345, 62024978, 62104374, 62124040, 62134006, 62200223, 62200224, 62233921, 62294595, 62314725, 62385328, 62436479, 62511942, 62544381, 62565042, 62597795, 62669933, 62696869, 62710618, 62736059, 62768447, 62043559, 62104415, 62121530, 62203396, 62203397, 62314728, 62314730, 62356529, 62390841, 62442847, 62511926, 62551396, 62565057, 62595859, 62654933, 62656069, 62720226, 62034569, 62055683, 62113088, 62130978, 62149714, 62165547, 62168384, 62177253, 62184260, 62256284, 62256285, 62397161, 62420223, 62511956, 62551402, 62565108, 62601570, 62696376, 62742762, 62756031, 62043561, 62055684, 62116593, 62145793, 62152728, 62166195, 62166196, 62168385, 62184261, 62239294, 62319851, 62320878, 62356546, 62390865, 62474905, 62538415, 62565044, 62581863, 62622558, 62632819, 62740693, 62398035, 62440437, 62515479, 62515499, 62563803, 62581853, 62675491, 62059520, 62079725, 62113046, 62144799, 62188423, 62188424, 62188425, 62290837, 62386431, 62436425, 62544361, 62564334, 62601567, 62669897, 62703452, 62742764, 62745001, 62059521, 62064136, 62079726, 62087046, 62104427, 62147239, 62189345, 62189346, 62189347, 62290841, 62351309, 62386782, 62442789, 62469458, 62525501, 62565090, 62565091, 62584448, 62595856, 62656017, 62689230, 62695893, 62710607, 62067441, 62104432, 62130980, 62177257, 62196631, 62196634, 62196637, 62315142, 62315143, 62386432, 62391240, 62442839, 62538411, 62564342, 62581858, 62624335, 62656070, 62686197, 62690916, 62695894, 62710620, 62059522, 62083318, 62104437, 62144801, 62156320, 62161539, 62162598, 62177259, 62239307, 62305411, 62391118, 62469434, 62544379, 62565031, 62595852, 62646287, 62686191, 62686296, 62709061, 62710631, 62746199, 62059523, 62104441, 62145794, 62152729, 62193852, 62193853, 62193854, 62290762, 62356651, 62386783, 62474908, 62531663, 62581867, 62601565, 62632632, 62663173, 62696858, 62697499, 62703451, 62759777, 62055688, 62104442, 62138319, 62187332, 62192904, 62192905, 62201541, 62290838, 62386784, 62436477, 62474904, 62531660, 62565036, 62581860, 62630286, 62658515, 62736051, 62751903, 62059524, 62062241, 62104443, 62138320, 62158149, 62158150, 62162599, 62177261, 62239308, 62255875, 62442842, 62511934, 62551335, 62564347, 62564351, 62624333, 62669906, 62696854, 62696855, 62732175, 62398036, 62440436, 62516039, 62563805, 62648144, and 62704599.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
  • Description du dispositif
    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

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