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Sign in to claim this brandWhat Synaptive Medical Inc makes
Synaptive Medical Inc develops specialized surgical and radiological tools for neurological and orthopedic procedures, including stereotactic navigation systems (e.g., BrightMatter Guide and Modus Nav software), surgical microscopes with integrated fluorescent angiography (Modus IR), and superconducting extremity MRI systems. Their portfolio also includes reusable suction cannulas and modular hardware like tracking arrays and pointer tools for precision-guided interventions. Radiological PACS software (e.g., ImageDrive Clinical) supports image management for clinical workflows.
The company’s devices are classified under FDA’s Class I and Class II regulatory categories and are listed in the FDA Unique Device Identifier (UDI) database. Their products are designed and distributed from 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 Synaptive Medical Inc manufacture?
Synaptive Medical Inc specializes in devices for neurological and orthopedic procedures. Their portfolio includes stereotactic surgery systems like the BrightMatter Guide and Modus Nav software, which assist in precision-guided interventions. They also produce surgical microscopes with integrated fluorescent angiography (e.g., Modus IR), superconducting extremity MRI systems, reusable suction cannulas, and modular hardware such as tracking arrays and pointer tools. Additionally, they offer radiological PACS software (e.g., ImageDrive Clinical) for image management in clinical settings.
Where is Synaptive Medical Inc based, and where are its devices designed and distributed?
Synaptive Medical Inc is based in the United States. All of its devices are designed and distributed from there, reflecting its focus on domestic innovation and regulatory compliance within the FDA framework.
Which regulatory registries or databases list Synaptive Medical Inc’s devices?
Synaptive Medical Inc’s devices are listed in the FDA Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, enabling them to verify device details and compliance information.
How are Synaptive Medical Inc’s devices classified under FDA regulations?
Synaptive Medical Inc’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring minimal regulatory oversight, while Class II involves moderate-risk devices with special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and clinical impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- synaptivemedical.com
- —
- —
- [email protected]
- Phone
- 844-462-7246
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 203061833
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BrightMatter Guide Software | 1.3 | FDA UDI | Class II | Active |
| Modus Nav Software | 2.2 | FDA UDI | Class II | Active |
| BrightMatter Plan | 1.5 | FDA UDI | Class II | Unknown |
| Modus Plan | 2.0 | FDA UDI | Class II | Active |
| Modus X | SYN-0974 | FDA UDI | Class I | Active |
| Tracking Array for Brainpath | SYN-0015 | FDA UDI | Class II | Active |
| ClearCanvas Personal Edition Workstation | 13.1 | FDA UDI | Class II | Unknown |
| BrightMatter Plan | 1.4 | FDA UDI | Class II | Unknown |
| ImageDrive Clinical | 1.1 | FDA UDI | Class II | Active |
| Modus Nav Operator Cart | SYN-0982 | FDA UDI | Class II | Active |
| BrightMatter Guide | SYN-0026 | FDA UDI | Class II | Active |
| Modus IR | SYN-0990 | FDA UDI | Class II | Active |
| Short Pointer | SYN-0559 | FDA UDI | Class II | Active |
| Pointer Tool (SS) | SYN-0013 | FDA UDI | Class II | Active |
| BrightMatter Patient Reference | SYN-0021 | FDA UDI | Class II | Active |
| BrightMatter Plan | 1.3 | FDA UDI | Class II | Unknown |
| BrightMatter Guide Software | 1.5 | FDA UDI | Class II | Active |
| BrightMatter Guide Sterilizable Storage Tray | SYN-0022 | FDA UDI | Class II | Active |
| Modus V | SYN-0902 | FDA UDI | Class I | Active |
| ImageDrive Pro | 1.1 | FDA UDI | Class II | Unknown |
| Modus Plan | 2.1 | FDA UDI | Class II | Active |
| BrightMatter Plan | 1.6 | FDA UDI | Class II | Unknown |
| Evry | SYN-0777 | FDA UDI | Class II | Active |
| Modus Nav Software | 2.1 | FDA UDI | Class II | Active |
| BrightMatter Guide Software | 1.4 | FDA UDI | Class II | Active |
| Trackable Suction - Suction Handle | SYN-0647 | FDA UDI | Class II | Active |
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