Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSurgical Information Sciences, Inc.
US
Last updated May 30, 2026
What Surgical Information Sciences, Inc. makes
The company develops software applications for stereotactic systems, including versions such as SIS System (5.6.0, 5.1.0) and SIS Software (3.6.0, 3.3.0). These tools are designed to assist in precision-guided surgical procedures, supporting navigation and planning functions within neurosurgical and orthopedic workflows.
The portfolio consists of Class II medical devices, regulated under FDA pathways including 510(k) clearance and UDI compliance. These products are listed in the FDA’s regulatory databases and are intended for use in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Surgical Information Sciences, Inc. manufacture?
Surgical Information Sciences, Inc. specializes in developing software applications for stereotactic systems. These tools, such as the SIS System (including versions like 5.6.0 and 5.1.0) and SIS Software (e.g., versions 3.6.0 and 3.3.0), are designed to support precision-guided surgical procedures. They assist in navigation and planning for neurosurgical and orthopedic workflows, ensuring accurate targeting and surgical planning.
Where is Surgical Information Sciences, Inc. based?
Surgical Information Sciences, Inc. is based in the United States. The company’s devices are developed and regulated under U.S. medical device standards, including FDA pathways.
Which regulatory registries list Surgical Information Sciences, Inc.’s devices?
The company’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) clearance pathway and the Unique Device Identifier (UDI) program. These registries ensure compliance with U.S. medical device regulations and provide transparency on authorised products.
How are Surgical Information Sciences, Inc.’s devices classified under FDA regulations?
The devices produced by Surgical Information Sciences, Inc. fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as software for stereotactic systems used in precision-guided surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- surgicalis.com
- —
- —
- [email protected]
- Phone
- 7633072401
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080367988
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SIS System | 6.X.X, 7.X.X | FDA UDI | Class II | Active |
| SIS System (Version 5.6.0) | K223032 | FDA 510(k) | Class II | Active |
| SIS Software | K162830 | FDA 510(k) | Class II | Active |
| SIS System (Version 5.1.0) | K210071 | FDA 510(k) | Class II | Active |
| SIS System | K230977 | FDA 510(k) | Class II | Active |
| SIS Software Version 3.6.0 | K192304 | FDA 510(k) | Class II | Active |
| SIS Software version 3.3.0 | K183019 | FDA 510(k) | Class II | Active |
| SIS System | K241083 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.