INRO MEDICAL DESIGNS, INC.

INRO Medical Designs, Inc. specializes in single-use hand and finger splints. Their devices, such as the INRO Surgical Nail and NAIL SPLINT, are designed to provide temporary immobilization and support for injured digits. These products fall under the category of orthopedic support devices.

INRO Medical Designs, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA categorizes these products under Class I or Class II (Unclassified) classifications, requiring compliance with U.S. medical device authorization pathways.

Devices from INRO Medical Designs, Inc. are recorded in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track submissions and device identification for compliance and transparency purposes.

INRO Medical Designs, Inc. devices are classified as either FDA Class I or Class II (Unclassified). Class I devices generally pose the lowest risk and may require less regulatory scrutiny, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorization.