Regulatory

Orthopedic Medical Device Manufacturer

IonFusion Surgical™ complies with State and Federal regulations regarding the manufacture and sale of medical devices. Coating Services Group, LLC., IonFusion Surgical's manufacturing facility, is registered with the FDA and licensed in the State of California as a medical device manufacturer.

• FDA Owner/Operator No.: 9057429
• FDA Establishment Registration No.: 2032803
• FDA Device Listings: Scalpel Blades and Saw Blades
• California Medical Device Manufacturing License No.: 48550