BENVENUE MEDICAL, INC.

Benvenue Medical, Inc. manufactures polymeric spinal fusion cages that are sterile, bone access cannulas, bone access channel kits, bone graft delivery kits, vertebral bone biopsy procedure kits (single-use), orthopaedic cement (non-antimicrobial), orthopaedic cement injection cannulas, and orthopaedic cement preparation/delivery kits. These products are designed for use in spinal and orthopaedic procedures, with the polymeric spinal fusion cage being the most commonly listed device category.

Benvenue Medical, Inc. is based in the United States, as explicitly stated in the provided device data under the COUNTRY field. The company’s location is confirmed in the SUMMARY section, which notes that the company operates within the U.S. regulatory environment.

Benvenue Medical, Inc.'s devices are listed in the FDA 510(k) database and the FDA UDI (Unique Device Identification) system, as specified in the LISTED IN field. These registries are used to track and authorize medical devices marketed in the United States, and the company’s inclusion in them reflects that individual devices have undergone the appropriate regulatory pathways for market entry.

Benvenue Medical, Inc.'s devices are classified as Class I and Class II medical devices, as indicated in the DEVICE CLASSES field. This classification reflects the level of regulatory control required to ensure safety and effectiveness, with Class I devices subject to general controls and Class II devices requiring special controls in addition to general controls. The classification is based on the intended use and risk profile of the devices, such as spinal fusion cages and bone access tools.