Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Orthopedic Spatula Regulations

U.S. FDA Medical Device Orthopedic Spatula Requirements

FDA Medical Device Definition: A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Registrar Corp assists Orthopedic Spatula companies with:

  • FDA Orthopedic Spatula Establishment Registration
  • FDA Orthopedic Spatula Listing
  • FDA Orthopedic Spatula Label Requirements and Exceptions
  • FDA Orthopedic Spatula Import Information
  • FDA Orthopedic Spatula Detentions (Orthopedic Spatula Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Orthopedic Spatula Manufacturers (Orthopedic Spatula Suppliers)
       - Orthopedic Spatula Distributors
       - Orthopedic Spatula Processors
       - Orthopedic Spatula Repackers
       - Orthopedic Spatula Relabelers
       - Orthopedic Spatula Exporters
       - Orthopedic Spatula Importers
For more information about Orthopedic Spatula 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco