Zsfab, Inc.

Zsfab, Inc. specializes in metallic spinal interbody fusion cages and associated surgical instruments. These devices are primarily used for spinal fusion and stabilization in the cervical (neck) and lumbar (lower back) regions of the spine. The company’s portfolio focuses on products designed to support surgical procedures aimed at improving spinal alignment and promoting bone fusion.

Zsfab, Inc. is based in the United States, which means its devices are subject to FDA regulations. The FDA classifies the company’s products as either Class I or Class II, depending on their risk level and intended use. This classification determines the regulatory pathway for authorization, such as 510(k) clearance for Class II devices.

Yes, Zsfab, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to verify the identity and authorization status of the devices. It also supports post-market surveillance and compliance efforts.

Zsfab, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may require general controls for authorization, while Class II devices involve moderate risk and typically require premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. The classification reflects the level of scrutiny and regulatory oversight needed to ensure safety and effectiveness.