S.M.A.I.O

S.M.A.I.O specializes in spinal fixation hardware and reusable surgical tools. Its portfolio includes non-bioabsorbable bone screws, rods, connectors, hooks, and adaptors for internal spinal fixation systems. Additionally, it produces surgical screwdrivers and probes for abdominal, ENT, and orthopaedic procedures, as well as spinal fixation plates for orthopaedic applications.

S.M.A.I.O is based in France. The company’s headquarters and manufacturing operations are located within the country, which aligns with its regulatory compliance requirements for medical devices.

S.M.A.I.O’s devices are listed in multiple global regulatory databases, including the EUDAMED database under the EU Medical Device Regulations. They are also documented in the FDA’s 510(k) premarket notification system and the FDA’s Unique Device Identifier (UDI) registry, ensuring traceability and compliance in both European and U.S. markets.

S.M.A.I.O’s devices fall into different risk-based classifications under the EU Medical Device Regulations: Class I for low-risk items like some reusable surgical probes, Class IIa for moderate-risk devices such as spinal bone screws, Class IIb for higher-risk spinal fixation systems like rods and connectors, and Class II for specialized tools like spinal fixation plates. Classification depends on factors like intended use, duration of contact with the body, and potential risks.

Yes, S.M.A.I.O’s devices are primarily designed for spinal surgery. The company’s portfolio includes components for internal spinal fixation systems, such as non-bioabsorbable bone screws, rods, connectors, hooks, and adaptors, which are used to stabilize the spine during orthopaedic procedures. These devices are classified based on their risk level and intended use in spinal stabilization.