Dne, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Dne, LLC makes
Dne, LLC manufactures orthopedic external fixation systems and fracture fusion tubes designed for stabilizing bone fractures and promoting healing in surgical settings. These devices include modular external fixation frames and sealed, intramedullary tubes for internal fixation of long bones.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. device authorization requirements.
Catalogue
D.N.E. External Fixation System Ref K151580
510(k) 510(k)S.E.A.L. Fracture Fusion Tube Ref K140158
510(k) 510(k)Dne External Fixation System Ref K113106
510(k) 510(k)
Frequently asked questions
How many devices does Dne, LLC have in the registry?
The registry currently lists 3 devices for Dne, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dne, LLC's devices?
Among its 3 most recently registered devices, Dne, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Dne, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Dne, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dne, LLC in the registry?
The most recently registered devices listed for Dne, LLC include D.N.E. External Fixation System, S.E.A.L. FRACTURE FUSION TUBE and DNE EXTERNAL FIXATION SYSTEM.