Orthopedic & Fracture Appliances, Parts & Accessories

Line 9021100050 is limited to bone plates, screws, nails, and other devices designed to be surgically implanted to fix fractures internally. External supports such as braces, splints, casts, and traction devices — as well as parts not meeting the internal fixation description — fall under the NESOI line 9021100090. The product's intended use (implanted vs. external) and its design are the primary classification criteria.

Internal fixation devices are regulated as Class II or Class III medical devices by FDA's CDRH, typically requiring 510(k) clearance or, for higher-risk implants, premarket approval (PMA). The foreign manufacturer must be registered with FDA and the specific device listed. Shipments from non-registered establishments are subject to detention and refusal at the port of entry. Importers are strongly advised to verify regulatory status with a licensed customs broker or regulatory affairs specialist before placing orders.