Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
United StatesFDA applicant, unverified
- Devices
- 3
What Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic makes
Icon Orthopedic Concepts, LLC (Edge Orthopaedic) manufactures orthopedic fixation systems, including the VIEW Plating System and REDUCE Fracture Plating System, along with associated bone screws. These products are designed for internal fixation of fractures, providing stability to bone fragments during healing. The REDUCE Fracture Plating System also includes line extensions for expanded clinical applications.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. These products are listed in the FDA’s 510(k) database, reflecting their regulatory authorization in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Edge Orthopaedics Bite Compression Screw Ref K132893
Regimes: 510(k) Registry: 510(k)Reduce Fracture Plating System Line Extension Ref K142135
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic have in the registry?
The registry currently lists 3 devices for Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic. Devices recorded under merged duplicate company entries are counted once.
Which registries list Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic's devices?
Among its 3 most recently registered devices, Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic has devices listed in FDA 510(k) (3 devices).
What risk classes do Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic in the registry?
The most recently registered devices listed for Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic include VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM, BONE SCREW, EDGE ORTHOPAEDICS BITE COMPRESSION SCREW and REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION.