Registrar Corp

HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Knee Joint Patellofemorotibial Prosthesis Regulations

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

FDA Medical Device Definition: A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. 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 base plate

Registrar Corp assists Knee Joint Patellofemorotibial Prosthesis companies with:

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




Live Help

 
U.S. FDA Regulations:

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


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco