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U.S. FDA Medical Device Surgical Instrument Motor Requirements


FDA Medical Device Definition: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Registrar Corp assists Surgical Instrument Motor companies with:

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






 
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.
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