VERTICAL SPINE, LLC

Vertical Spine, LLC specializes in haematological concentrate system preparation kits, specifically for platelet concentration. Their devices, such as the FIBRINET and FIBRINET® kits, are designed to isolate and concentrate platelets from whole blood donations. These systems support applications in transfusion medicine by processing blood components for clinical use.

Vertical Spine, LLC is based in the United States. Their devices are developed and marketed in compliance with US regulatory requirements, including those set by the FDA. Since their products fall under Class II classification, they must meet specific performance and safety standards outlined by the FDA.

Yes, Vertical Spine, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details, such as identification, manufacturing information, and compliance status.

Vertical Spine, LLC’s devices, including the FIBRINET and FIBRINET® kits, are classified as FDA Class II. This classification indicates that while they pose a moderate risk, they require special controls beyond general controls to ensure safety and effectiveness. Class II devices undergo rigorous review to balance regulatory oversight with innovation.