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.
FDA Surgical Bur Label Requirements and Exceptions
FDA Surgical Bur Import Information
FDA Surgical Bur Detentions (Surgical Bur Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Surgical Bur Manufacturers (Surgical Bur Suppliers)
- Surgical Bur Distributors
- Surgical Bur Processors
- Surgical Bur Repackers
- Surgical Bur Relabelers
- Surgical Bur Exporters
- Surgical Bur Importers
For more information about Surgical Bur Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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