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7D Surgical ULC

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
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 204326292

Catalogue (105)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
7D Surgical Drill Guide Verification Insert	11-0090	FDA UDI	Class II	Active
7D Surgical Cranial Articulating Arm	11-0008	FDA UDI	Class II	Active
7D Surgical Facet Array Adaptor	11-0087	FDA UDI	Class II	Active
7D Surgical Iliac Single Pin Sterilization Tray	11-0108	FDA UDI	Class II	Active
7D Surgical Dual Starburst Connector	11-0022	FDA UDI	Class II	Active
7D Surgical Iliac Cross Pin, 150 mm	11-0104	FDA UDI	Class II	Active
7D Surgical 3.5 mm Hex Screwdriver	11-0029	FDA UDI	Class II	Active
7D Surgical Steinmann Pin (ø3.2mm x 150mm)	11-0031	FDA UDI	Class II	Active
7D Surgical Lumbar Sterilization Tray	11-0014	FDA UDI	Class II	Active
Envision 3d: Image Guidance System	10-0001	FDA UDI	Class II	Active
7D Surgical Cranial Pointer	11-0009	FDA UDI	Class II	Active
7D Surgical Modular 2.2mm Drill Bit	11-0037	FDA UDI	Class II	Active
7D Surgical Pointer	11-0009	FDA UDI	Class II	Active
7D Surgical Biopsy Sterilization Tray	11-0026	FDA UDI	Class II	Active
Envision 3d: Light Handle	11-0005	FDA UDI	Class II	Active
7D Surgical Ratcheting Handle, 1/4" Square	11-0076	FDA UDI	Class II	Active
7D Surgical Iliac Cannula, 150 mm	11-0102	FDA UDI	Class II	Active
7D Surgical Cranial Articulating Arm	11-0008	FDA UDI	Class II	Active
7D Surgical FlashLock 3	11-0035	FDA UDI	Class II	Active
7D Surgical Flex Rod Connector - ø5.5mm - 100mm	11-0051	FDA UDI	Class II	Active
Envision 3d: Reference Clamp	11-0003	FDA UDI	Class II	Active
7D Surgical Universal Array 4	11-0094	FDA UDI	Class II	Active
7D Surgical Universal Array (6)	11-0142	FDA UDI	Class II	Active
7D Surgical Universal Array 3	11-0093	FDA UDI	Class II	Active
7D Surgical Sterilization Tray (Pedicle Preparation)	11-0075	FDA UDI	Class II	Active
7D Surgical Reference Sterilization Tray	11-0070	FDA UDI	Class II	Active
7D Surgical 2.1mm Drill Bit	11-0044	FDA UDI	Class II	Active
7D Surgical Iliac Cannula, 100 mm	11-0099	FDA UDI	Class II	Active
7D Surgical Inserter, Lumbar	11-0085	FDA UDI	Class II	Active
Envision 3d: Awl	11-0001	FDA UDI	Class II	Active
7D Surgical Iliac Dilator, 150 mm	11-0103	FDA UDI	Class II	Active
7D Surgical Spine Sterilization Tray	11-0004	FDA UDI	Class II	Active
7D Surgical Flex Rod Connector - 5.5 mm - 50 mm	11-0050	FDA UDI	Class II	Active
7D Surgical Universal Array (5)	11-0141	FDA UDI	Class II	Active
7D Surgical Flex Array	11-0053	FDA UDI	Class II	Active
7D Surgical Universal Clamp Large	11-0019	FDA UDI	Class II	Active
7D Surgical Iliac Single Pin Connector	11-0107	FDA UDI	Class II	Active
7D Surgical Cranial Reference Frame	11-0007	FDA UDI	Class II	Active
7D Surgical Iliac Dilator, 100 mm	11-0100	FDA UDI	Class II	Active
7D Surgical Hex Screwdriver (4mm Nut Driver)	11-0097	FDA UDI	Class II	Active
7D Surgical Steinmann Pin (ø4.0mm x 150mm)	11-0032	FDA UDI	Class II	Active
7D Surgical Pedicle Probe (Sharp)	11-0055	FDA UDI	Class II	Active
7D Surgical Iliac Tap Cap	11-0105	FDA UDI	Class II	Active
7D Surgical Spine Reference Clamp (Multi-Level)	11-0098	FDA UDI	Class II	Active
7D Surgical Registration Frame	11-0066	FDA UDI	Class II	Active
7D Surgical Universal Tracking Sterilization Tray	11-0143	FDA UDI	Class II	Active
7D Surgical Biopsy Arm	11-0025	FDA UDI	Class II	Active
7D Surgical Universal Clamp Small	11-0018	FDA UDI	Class II	Active
7D Surgical 3.0 mm Hex Screwdriver	11-0058	FDA UDI	Class II	Active
7D Surgical 10mm Hex Nut Screwdriver	11-0078	FDA UDI	Class II	Active

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FDA Establishments (1)

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7d Surgical Ulc Toronto Ontario · CA FEI 3012098629