Flospine

Flospine specializes in orthopaedic and spinal fixation devices. Their portfolio includes non-bioabsorbable bone screws (such as spinal screws), spinal fixation plates, metallic interbody fusion cages, internal spinal fixation rod systems, reusable surgical probes for abdominal/ENT/orthopaedic use, wire-holding pliers, and single-use fluted surgical drill bits. These devices are designed to support surgical procedures in orthopaedics and spinal care.

Flospine is based in the United States. Since it manufactures medical devices, its products fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The company’s devices are subject to FDA compliance requirements, including classification and registration in relevant databases like the FDA’s Unique Device Identifier (UDI) system.

Flospine’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for medical devices regulated by the FDA, allowing healthcare providers, regulators, and other stakeholders to identify and verify specific products.

Flospine’s devices are classified under two categories by the FDA: Class I and Class II. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and regulatory history, ensuring appropriate oversight for patient safety.