Dunamis, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Dunamis, LLC makes
Dunamis, LLC manufactures orthopedic fixation devices, including absorbable and non-absorbable sutures (sizes 2 and 5), interference screws, suture anchors made from PEEK in multiple diameters (3.0mm to 6.5mm), a fixation button system for bone stabilization, tensile tape for reinforcement, and punch-style suture anchors.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. Dunamis, LLC is based in the United States.
Catalogue
- 510(k) 510(k)
Dunamis Interference Screw Ref K151220
510(k) 510(k)- 510(k) 510(k)
Dunamis Fixation Button System Ref K191319
510(k) 510(k)Dunamis Force DFX Tensile Tape Ref K153746
510(k) 510(k)Dunamis PunchTac Suture Anchors Ref K193245
510(k) 510(k)
Frequently asked questions
How many devices does Dunamis, LLC have in the registry?
The registry currently lists 6 devices for Dunamis, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dunamis, LLC's devices?
Among its 6 most recently registered devices, Dunamis, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do Dunamis, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Dunamis, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dunamis, LLC in the registry?
The most recently registered devices listed for Dunamis, LLC include Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2, Dunamis Interference Screw, Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm and Dunamis Fixation Button System.