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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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4.0 MM X 2.35 MM X 49.0 MM STRAIGHT DERMABRADER DIAMOND BUR
Omega Surgical Instruments Inc
H-180
In Commercial Distribution

  • 00817438021435 ()


  • Podiatric bur, single-use
12.0 MM X 2.35 MM X 49.0 MM STRAIGHT DERMABRADER DIAMOND BUR
Omega Surgical Instruments Inc
H-182
In Commercial Distribution

  • 00817438021459 ()


  • Podiatric bur, single-use
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209357
In Commercial Distribution

  • M268102093571 ()
  • 10381780238096 ()

  • Size 3, Left, 7mm, Posterior Biased
10209357

  • Fixed-bearing total ankle prosthesis
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209356
In Commercial Distribution

  • M268102093561 ()
  • 10381780238089 ()

  • Size 3, Left, 6mm, Posterior Biased
10209356

  • Fixed-bearing total ankle prosthesis
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209352
In Commercial Distribution

  • M268102093521 ()
  • 10381780238072 ()

  • Size 3, Right, 12mm, Posterior Biased
10209352

  • Fixed-bearing total ankle prosthesis
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209351
In Commercial Distribution

  • M268102093511 ()
  • 10381780238065 ()

  • Size 3, Right, 11mm, Posterior Biased
10209351

  • Fixed-bearing total ankle prosthesis
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209350
In Commercial Distribution

  • M268102093501 ()
  • 10381780238058 ()

  • Size 3, Right, 10mm, Posterior Biased
10209350

  • Fixed-bearing total ankle prosthesis
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209349
In Commercial Distribution

  • M268102093491 ()
  • 10381780238041 ()

  • Size 3, Right, 9mm, Posterior Biased
10209349

  • Fixed-bearing total ankle prosthesis
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209348
In Commercial Distribution

  • M268102093481 ()
  • 10381780238034 ()

  • Size 3, Right, 8mm, Posterior Biased
10209348

  • Fixed-bearing total ankle prosthesis
The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Ascension Orthopedics, Inc.
10209347
In Commercial Distribution

  • M268102093471 ()
  • 10381780238027 ()

  • Size 3, Right, 7mm, Posterior Biased
10209347

  • Fixed-bearing total ankle prosthesis
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