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

Catalogue (105)

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Device	Model / Reference	Registries	Class	Status
7D Surgical Pin Guide Block	11-0036	FDA UDI	Class II	Active
7D Surgical Universal Tracking Sterilization Tray	11-0084	FDA UDI	Class II	Active
7D Surgical Awl	11-0001	FDA UDI	Class II	Active
7D Surgical Flash Frame (Localizer)	11-0110	FDA UDI	Class II	Active
7D Surgical Pointer (Ball Tip)	11-0054	FDA UDI	Class II	Active
7D Surgical Trocar Insert	11-0040	FDA UDI	Class II	Active
7D Surgical System	10-0001	FDA UDI	Class II	Active
7D Surgical FLASH Frame	11-0048	FDA UDI	Class II	Active
7D Surgical FLASHTM Lock Sterilization Tray	11-0059	FDA UDI	Class II	Active
7D Surgical Awl (Lumbar)	11-0012	FDA UDI	Class II	Active
7D Surgical Navigation Guide, T-Handle	11-0086	FDA UDI	Class II	Active
7D Surgical Pedicle Probe (Slim)	11-0092	FDA UDI	Class II	Active
7D Surgical Pedicle Probe	11-0002	FDA UDI	Class II	Active
7D Surgical Flex Iliac Pin Connector	11-0030	FDA UDI	Class II	Active
7D Surgical Pedicle Probe (Lumbar)	11-0013	FDA UDI	Class II	Active
Envision 3d: Pedicle Probe	11-0002	FDA UDI	Class II	Active
7D Surgical 3mm Drill Bit (Short)	11-0089	FDA UDI	Class II	Active
Short Drill Guide Sterilization Tray	11-0091	FDA UDI	Class II	Active
7D Surgical Universal Clamp (SeaSpine Adapter)	11-0079	FDA UDI	Class II	Active
7D Surgical Biopsy Guide	11-0024	FDA UDI	Class II	Active
7D Surgical Universal Calibration Device	11-0017	FDA UDI	Class II	Active
11-0052 7D Flex Rod Connector - ø5.5mm - 150mm	11-0052	FDA UDI	Class II	Active
7D Surgical Spine Reference Clamp (Stainless Steel)	11-0068	FDA UDI	Class II	Active
7D Surgical Chuck Key	11-0071	FDA UDI	Class II	Active
7D Surgical FlashLock 1	11-0033	FDA UDI	Class II	Active
7D Surgical Iliac Cross Pin, 100 mm	11-0101	FDA UDI	Class II	Active
7D Surgical Drill Guide Sterilization Tray	11-0056	FDA UDI	Class II	Active
7D Surgical Iliac Dual Pin Sterilization Tray	11-0125	FDA UDI	Class II	Active
7D Surgical Cranial Sterilization Tray	11-0010	FDA UDI	Class II	Active
7D Surgical Bit Guide – Aggressive Insert	11-0042	FDA UDI	Class II	Active
7D Surgical Drill Bit Stopper	11-0045	FDA UDI	Class II	Active
7D Surgical Light Handle	11-0005	FDA UDI	Class II	Active
7D Surgical Spine Reference Clamp	11-0003	FDA UDI	Class II	Active
7D Surgical Flex Rod Connector (4.5 mm - 100 mm)	11-0113	FDA UDI	Class II	Active
7D Surgical Reference Clamp (Gator)	11-0096	FDA UDI	Class II	Active
7D Surgical AO Pull Adapter	11-0077	FDA UDI	Class II	Active
7D Surgical Universal Clamp Sterilization Tray	11-0020	FDA UDI	Class II	Active
7D Surgical Drill Guide	11-0039	FDA UDI	Class II	Active
7D Surgical Cranial Reference Frame	11-0007	FDA UDI	Class II	Active
7D Surgical FlashLock 2	11-0034	FDA UDI	Class II	Active
7D Surgical Bit Guide – 3.0mm Insert	11-0041	FDA UDI	Class II	Active
7D Surgical Spine Reference Clamp (Radiolucent)	11-0057	FDA UDI	Class II	Active
7D Surgical Universal Array 2	11-0016	FDA UDI	Class II	Active
7D Surgical 3.0mm Drill Bit	11-0043	FDA UDI	Class II	Active
7D Surgical T-Handle Chuck	11-0069	FDA UDI	Class II	Active
7D Surgical Iliac Slap Hammer	11-0106	FDA UDI	Class II	Active
7D Surgical Cranial Sterilization Tray	11-0010	FDA UDI	Class II	Active
7D Surgical Drill Guide (Short)	11-0083	FDA UDI	Class II	Active
7D Surgical Universal Clamp (Stryker Adapter)	11-0067	FDA UDI	Class II	Active
7D Surgical 2mm Drill Bit (Short)	11-0088	FDA UDI	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