Zimmer Biomet, Inc.

171 devices in the database

  • Model / Serial
    42-5399-035-08/09/10/12/14 (Sizes 8mm, 9mm, 10mm, 12mm, 14mm)  Lot numbers: 63552644 63579568 63547276 63579569 63610265 63549084 63579674 63594433 63610266 63549096 63579676 63594434 63610267 63549097 63579680 63596547 63613101
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Persona Partial Knee Spacer Blocks || To assist in partial knee arthroplasty surgery
  • Model / Serial
    Package Lot: 989430; Lot Etched on Product: P0284
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
  • Product Description
    A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
  • Model / Serial
    Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
  • Product Description
    fastener, fixation, nondegradable, soft tissue
  • Model / Serial
    The kits that include the TunneLoc products, ACL in a box, PNs 906532, 906533, 906534, and 906535 are packed in a box alongside the Instructions for use and is distributed non-sterile .
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    TunneLoc Tibial Fixation Device (Within an ACL Kit) || Product Usage: || To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
  • Model / Serial
    906512, 906513, 906514, 906515
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    TunneLoc Tibial Fixation Device || Product Usage: || To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
166 more

2 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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
  • 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.
  • Manufacturers representative
    INTERMEDIC S.A.L.
  • Source
    RLMPH