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