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Sign in to claim this brand7D Surgical ULC
US
Last updated May 23, 2026
What 7D Surgical ULC makes
The company manufactures reusable surgical tools and systems for orthopaedic and stereotactic procedures, including optical-tracking connectors, drill chucks, and sterilization trays for bone pins. Their portfolio also includes single-use imaging markers for lesion localization and mobile navigation workstations for surgical planning. Specific products cover cranial and spinal applications, such as articulating arms, hex screwdrivers, and modular drill bits designed for precision in spinal and orthopaedic surgeries.
All listed devices fall under FDA Class II regulation, requiring premarket notification (510(k)) or a De Novo classification for novel technologies. The company’s products are registered under the FDA’s 510(k) and Unique Device Identification (UDI) systems, ensuring traceability and compliance with US medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 204326292
Catalogue (105)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 7D Surgical Universal Array Angled Adaptor | 11-0049 | FDA UDI | Class II | Active |
| 7D Surgical Universal Array 1 | 11-0015 | FDA UDI | Class II | Active |
| 7D Surgical 2.5mm Hex Screwdriver | 11-0023 | FDA UDI | Class II | Active |
| ENVISION 3D: Sterilization Tray | 11-0004 | FDA UDI | Class II | Active |
| FLASH EVD System (10-0002) | K242480 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- 7d Surgical Ulc Toronto Ontario · CA FEI 3012098629