Affixus Intramedullary Hip Fracture Nail

  • Model / Serial
    Item No. 814309260; Lot No. (Exp. Date) UDI: 702050 (06/12/2027) UDI (01)00887868037979 (17)270612 (10)702050
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution. Also Portugal and the Netherlands.
  • Product Description
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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

63 devices with a similar name

Learn more about the data here

  • Model / Serial
    Item No. 814611460; Lot No. (Exp. Date) UDI: 555810 (05/27/2027) UDI (01)00887868039867 (17)270527 (10)555810; 788580 (07/17/2027) UDI (01)00887868039867 (17)270717 (10)788580
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution. Also Portugal and the Netherlands.
  • Product Description
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
  • Manufacturer
  • Model / Serial
    Item No. 814613460; Lot No. (Exp. Date) UDI: 862150 (06/15/2027) UDI (01)00887868039980 (17)270615 (10)862150
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution. Also Portugal and the Netherlands.
  • Product Description
    Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
  • Manufacturer
  • Model / Serial
    Item No. 814309180, Lot No. 459250, Exp. Date 05/27/2027, UDI (01)00887868037962 (17)270527 (10)459250
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution. Also Portugal and the Netherlands.
  • Product Description
    Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
  • Manufacturer
  • Model / Serial
    Item No. 814511180, Lot No. 459170, Exp. Date 05/18/2027, (01)00887868039102 (17)270518 (10)459170
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution. Also Portugal and the Netherlands.
  • Product Description
    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
  • Manufacturer
  • Model / Serial
    Item No. 814509180, Lot No. 459290, Exp. Date 05/17/2027, (01)00887868038846 (17)270517 (10)459290
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution. Also Portugal and the Netherlands.
  • Product Description
    Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
  • Manufacturer
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