Kahtnu Surgical, Inc.

Kahtnu Surgical, Inc. specializes in spinal fixation devices. Their primary products include non-sterile bone-screw internal spinal fixation systems, such as the TALKEETNA 5.5 Lumbar Pedicle Screw System, which is designed for lumbar spine stabilization. They also produce vertebral body prostheses, including the KASILOF Cervical Plate System, intended for cervical spine fixation. These devices are engineered to support surgical interventions for spinal stability.

Kahtnu Surgical, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction for medical device authorization.

Kahtnu Surgical, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as spinal fixation systems and vertebral body prostheses. Class II devices typically require premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device.

Kahtnu Surgical, Inc.’s devices are listed in the FDA’s 510(k) registry, which tracks premarket notifications for Class II devices to demonstrate compliance with regulatory requirements. Additionally, their devices appear in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and transparency in the supply chain for spinal fixation products.