Dio Department Dsi, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Dio Department Dsi, Inc. makes
Dio Department Dsi, Inc. manufactures spinal implant systems, including internal and external fixation devices for orthopedic applications. Their portfolio includes systems for spinal stabilization, such as the BIOTITE-H, PROTEM, and SM series, as well as specialized variants like the SM-EXTRA WIDE (RBM) and SECURE (2.5/3.0mm) implants.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States, with its products registered in the FDA’s 510(k) clearance database.
Catalogue
Dio Biotite-H Implant System Ref K073070
Regimes: 510(k) Registry: 510(k)Dio Protem Implant System Ref K070568
Regimes: 510(k) Registry: 510(k)Sm Internal./External Implant System Ref K070569
Regimes: 510(k) Registry: 510(k)Sm Implant Systems Ref K061797
Regimes: 510(k) Registry: 510(k)Dio Implant System Ref K070570
Regimes: 510(k) Registry: 510(k)Sm-Extra Wide (Rbm) Implant System Ref K080128
Regimes: 510(k) Registry: 510(k)Dio Protem Implant System Ref K080126
Regimes: 510(k) Registry: 510(k)Secure Implant System (2.5/3.0mm) Ref K080129
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dio Department Dsi, Inc. have in the registry?
The registry currently lists 8 devices for Dio Department Dsi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dio Department Dsi, Inc.'s devices?
Among its 8 most recently registered devices, Dio Department Dsi, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Dio Department Dsi, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Dio Department Dsi, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dio Department Dsi, Inc. in the registry?
The most recently registered devices listed for Dio Department Dsi, Inc. include DIO BIOTITE-H IMPLANT SYSTEM, DIO PROTEM IMPLANT SYSTEM, SM INTERNAL./EXTERNAL IMPLANT SYSTEM and SM IMPLANT SYSTEMS.