Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
United StatesFDA applicant, unverified
- Devices
- 2
What Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) makes
Digital Surgery Systems, Inc. manufactures the Affirm 400 and Affirm 800, which are robotic surgical systems designed for minimally invasive procedures. These devices are intended to assist surgeons in performing precise, controlled movements during operations, supporting tasks such as tissue manipulation and instrument handling.
The company’s portfolio is regulated under Class II medical devices in the U.S., with devices listed via the FDA’s 510(k) pathway. The systems are based in the United States.
Catalogue
Affirm 400 Ref K251286
Regimes: 510(k) Registry: 510(k)Affirm 800 Ref K243077
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) have in the registry?
The registry currently lists 2 devices for Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). Devices recorded under merged duplicate company entries are counted once.
Which registries list Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)'s devices?
Among its 2 most recently registered devices, Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) has devices listed in FDA 510(k) (2 devices).
What risk classes do Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) in the registry?
The most recently registered devices listed for Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) include Affirm 400 and Affirm 800.