J.M. Longyear Manufacturing, LLC

J.M. Longyear Manufacturing, LLC focuses on orthopaedic and sternal fixation devices. Their portfolio includes sternal fixation devices, non-sliding orthopaedic bone screws, reusable positioning instruments for orthopaedic prosthesis implantation, non-bioabsorbable fixation plates, and single-use surgical screwdrivers. They also produce rib and thoracic fixation systems, such as the Valkyrie Rib Thoracic Fixation System, which is designed for internal skeletal stabilization in thoracic surgeries.

J.M. Longyear Manufacturing, LLC is based in the United States. Their devices are manufactured domestically, ensuring compliance with applicable U.S. regulatory requirements for medical device authorization.

J.M. Longyear Manufacturing, LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This system helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare supply chain.

J.M. Longyear Manufacturing, LLC’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on the specific device type and its intended use.

The Valkyrie Rib Thoracic Fixation System is designed for internal skeletal fixation in thoracic surgeries. It provides stabilization to the rib cage and thoracic spine, helping to maintain proper alignment and support during the healing process after procedures such as spinal or rib cage surgeries.