Insight Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Insight Medical Systems, Inc. makes
Insight Medical Systems, Inc. manufactures the ARVIS® Shoulder, a device for orthopedic shoulder surgery, and the ARVIS Surgical Navigation System, a tool for intraoperative navigation and guidance during joint procedures.
The company’s portfolio consists of Class II devices, authorised via the FDA’s 510(k) pathway. These products are listed under the FDA’s regulatory framework and are based in the United States.
Catalogue
ARVIS® Shoulder Ref K240062
Regimes: 510(k) Registry: 510(k)ARVIS Surgical Navigation System Ref K203115
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Insight Medical Systems, Inc. have in the registry?
The registry currently lists 2 devices for Insight Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insight Medical Systems, Inc.'s devices?
Among its 2 most recently registered devices, Insight Medical Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Insight Medical Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Insight Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Insight Medical Systems, Inc. in the registry?
The most recently registered devices listed for Insight Medical Systems, Inc. include ARVIS® Shoulder and ARVIS Surgical Navigation System.