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U.S. FDA Medical Device Surgical Saw Blade 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 Saw Blade companies with:

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