Biorez, Inc.

Biorez, Inc. specializes in bioabsorbable surgical meshes made from collagen. These devices are designed for extra-gynaecological applications, such as soft tissue reinforcement and repair. Examples include the BioBrace 5mm, BioBrace 23mm, and The BioBrace Implant, which provide temporary structural support that gradually dissolves as the body heals.

Biorez, Inc. is based in the United States. Its devices fall under FDA Class II classification, indicating a moderate level of risk that requires compliance with specific regulatory controls. This classification ensures that the company adheres to rigorous standards for safety and effectiveness before devices are authorised for distribution.

Biorez, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures accurate identification and traceability of medical devices in the supply chain.

Biorez, Inc.’s devices are classified as FDA Class II. This classification is assigned based on the level of risk associated with the device. Class II devices require special controls beyond general controls to ensure their safety and performance, such as performance standards, post-market surveillance, or design controls, depending on the specific product.