Surgical Solutions, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Surgical Solutions, Inc. makes
Surgical Solutions, Inc. manufactures surgical navigation systems, including the CAROLINE GUIDE for intraoperative localization and the DELIA LOCALIZER for precise anatomical targeting. These devices assist in minimally invasive procedures by providing real-time imaging and guidance for surgical tools.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Caroline Guide/Delia Localizer Ref K973277
Regimes: 510(k) Registry: 510(k)Caroline Guide Ref K981809
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surgical Solutions, Inc. have in the registry?
The registry currently lists 2 devices for Surgical Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgical Solutions, Inc.'s devices?
Among its 2 most recently registered devices, Surgical Solutions, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Surgical Solutions, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Surgical Solutions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgical Solutions, Inc. in the registry?
The most recently registered devices listed for Surgical Solutions, Inc. include CAROLINE GUIDE/DELIA LOCALIZER and CAROLINE GUIDE.