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U.S. FDA Medical Device Knee Joint Femorotibial Prosthesis Requirements: Knee Joint Femorotibial Prosthesis

FDA Medical Device Definition: A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surface. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra-high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate

Registrar Corp assists Knee Joint Femorotibial Prosthesis companies with:

  • FDA Knee Joint Femorotibial Prosthesis Establishment Registration
  • FDA Knee Joint Femorotibial Prosthesis Listing
  • FDA Knee Joint Femorotibial Prosthesis Label Requirements and Exceptions
  • FDA Knee Joint Femorotibial Prosthesis Import Information
  • FDA Knee Joint Femorotibial Prosthesis Detentions (Knee Joint Femorotibial Prosthesis Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Knee Joint Femorotibial Prosthesis Manufacturers (Knee Joint Femorotibial Prosthesis Suppliers)
       - Knee Joint Femorotibial Prosthesis Distributors
       - Knee Joint Femorotibial Prosthesis Processors
       - Knee Joint Femorotibial Prosthesis Repackers
       - Knee Joint Femorotibial Prosthesis Relabelers
       - Knee Joint Femorotibial Prosthesis Exporters
       - Knee Joint Femorotibial Prosthesis Importers
For more information about Knee Joint Femorotibial Prosthesis Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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