SPINAL MODULATION, INC.

Spinal Modulation, Inc. specializes in single-use medical devices primarily for neurosurgical procedures. Their product line includes neurosurgical procedure kits (non-medicated), electrical-only connection cables designed for medical device integration, and non-threaded epidural needles. These devices are tailored for controlled surgical environments, such as spinal interventions, and are branded under Axium™ for various procedural applications.

Spinal Modulation, Inc. is based in the United States, which means its devices must comply with FDA regulations. Since all of their products fall under Class III classification—a category for high-risk devices—they must adhere to stringent pre-market approval (PMA) requirements and post-market surveillance standards. The company’s U.S. location also means its devices are subject to domestic regulatory oversight, including listing in the FDA’s Unique Device Identifier (UDI) database.

Spinal Modulation, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it ensures traceability, transparency, and compliance tracking for high-risk medical devices like those classified as Class III. The UDI system helps healthcare providers, regulators, and manufacturers verify device authenticity, recall history, and regulatory status, reducing risks in clinical settings.

The FDA categorizes devices into classes based on risk, with Class III being the highest due to their potential to cause serious harm or death if they fail. Spinal Modulation, Inc.’s devices—such as neurosurgical kits, connection cables, and epidural needles—are classified as Class III because they are intended for critical procedures like spinal interventions, where even minor malfunctions could have severe consequences. This classification requires rigorous pre-market approval and ongoing compliance to ensure patient safety.