Exactech, Inc. - FDA 510(k) Cleared Devices

Exactech, Inc. operates with a manufacturing facility in Gainesville, US. The company does not offer direct sales or distribution in the United States. Product inquiries and safety concerns are handled through designated company contacts.

Exactech has submitted 186 FDA 510(k) applications, resulting in 174 cleared devices. The company's regulatory activity spans from 1986 to 2026, demonstrating sustained engagement with FDA clearance processes. Orthopedic devices represent the dominant focus of the company's portfolio, accounting for approximately 99% of submissions.

Recent FDA 510(k) clearances reflect a concentrated focus on orthopedic surgical implants and reconstruction systems. The company's cleared devices include shoulder systems, knee systems, ankle systems, and fracture fixation solutions. This specialization positions Exactech within the established orthopedic device regulatory ecosystem.

Explore Exactech's complete FDA 510(k) clearance history, device categories, and regulatory records in the database.

Regulatory submissions have been managed by Empirical Consulting, LLC and Advita Ortho.