Royal Oak Medical Devices

Royal Oak Medical Devices is a precision medical device manufacturer specializing in orthopedic implants and components. Operating from an 18,000 sq ft state-of-the-art facility established in 2013 in Rochester Hills, Michigan, the company designs and manufactures FDA 510(k)-approved devices including pedicle screws, lumbar cages, and custom orthopedic components. The company works with advanced materials including titanium, cobalt chrome, stainless steel, PEEK, and thermoplastics. Manufacturing capabilities include multi-axis CNC turning and milling, wire EDM, ultrasonic cleaning with pharma-grade water, laser marking, and proprietary surface finishing techniques. The facility supports full capabilities from prototype development through full-scale production with in-house design engineering and consulting services. Quality systems include rigorous QC vision systems and lights-out manufacturing automation. The company is ISO 13485:2016 certified with design, 21 CFR 820 compliant, and FDA registered. Royal Oak Medical serves orthopedic device manufacturers and healthcare systems requiring custom implants and precision-machined components.