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U.S. FDA Medical Device Surgical Pin Driver 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 Pin Driver companies with:

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