Fusion Orthopedics USA, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Fusion Orthopedics USA, LLC - FDA 510(k) Cleared Devices
Recent clearances: Fusion FibFix Nail
1
Total
1
Cleared
0
Denied
Fusion Orthopedics USA, LLC designs and manufactures orthopedic surgical implants and fixation systems. The company operates with a manufacturing facility in Mesa, US.
The company has received 1 FDA 510(k) clearance from 1 total submission. Its regulatory activity spans 2026, with focus on orthopedic device development. The FibFix Nail System, a low-profile intramedullary nail for fibula fractures and osteotomies, represents the company's cleared portfolio.
Fusion Orthopedics offers a broad range of orthopedic solutions including bunion correction systems, syndesmotic fixation devices, external fixation platforms, and bone graft materials. The product portfolio spans foot and ankle surgery, with specialized implants for minimally invasive and open procedures.
Explore the company's cleared device names, product codes, and clearance dates in the FDA 510(k) database.
FDA 510(k) Regulatory Record - Fusion Orthopedics USA, LLC
1 devices