U.S. FDA Medical Device Orthopedic Burr Requirements
FDA Medical Device Definition: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
FDA Orthopedic Burr Label Requirements and Exceptions
FDA Orthopedic Burr Import Information
FDA Orthopedic Burr Detentions (Orthopedic Burr Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Orthopedic Burr Manufacturers (Orthopedic Burr Suppliers)
- Orthopedic Burr Distributors
- Orthopedic Burr Processors
- Orthopedic Burr Repackers
- Orthopedic Burr Relabelers
- Orthopedic Burr Exporters
- Orthopedic Burr Importers
For more information about Orthopedic Burr 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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