Total Temporomandibular Joint Replacement System

  • Model / Serial
    Model 24-6545TI, Lot #s: 520220B, 520220A, 520210A, 520210B
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
  • Product Description
    Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand || Reconstruction of the temporomandibular joint
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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

13 devices with a similar name

Learn more about the data here

  • Model / Serial
    Part #CP751506 Lot #478490
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to Denmark only.
  • Product Description
    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 || The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
  • Manufacturer
  • Model / Serial
    Models 24-6646TI, Lot #s: 526000A, 526000B, 526010B, 526010A, 535390A, 535390B, 535390C, 535390D, 538720A, 538720B, 538720C, 538720D
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
  • Product Description
    Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand || Reconstruction of the temporomandibular joint
  • Manufacturer
  • Model / Serial
    Model 01-6545TI, Lot #s: 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, 535380A.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
  • Product Description
    Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand || Reconstruction of the temporomandibular joint
  • Manufacturer
  • Model / Serial
    Model 24-6645TI, Lot #s: 472580A, 472590B, 472580B, 472590A, 526030A, 526020A, 526020B, 526030B.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
  • Product Description
    Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand || Reconstruction of the temporomandibular joint
  • Manufacturer
  • Model / Serial
    Model 01-6551TI, Lot #s: 535370A, 535370B, 535370C, 535370D.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
  • Product Description
    Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand || Reconstruction of the temporomandibular joint
  • Manufacturer
8 more