Data / Medical devices / Canada / 7D Surgical ULC
7D Surgical ULC: FDA-registered device maker in Toronto Ontario, Canada, 11 510(k) clearances
7D Surgical ULC is registered with the FDA (registration 3012098629) in Toronto Ontario, Canada. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012098629
- Address
- 60 Scarsdale Road, Unit 118, Toronto Ontario, Canada, M3B 2R7
- Owner or operator
- 7D Surgical ULC (10053763)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 9, 2017
- Registered through
- 2026
- Brand names listed
- FLASH EVD System, FLASH Navigation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 27, 2024 | K242480 | FLASH EVD System (10-0002) | HAW | Substantially Equivalent | 7D Surgical ULC | accessdata.fda.gov |
| May 20, 2022 | K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | OLO | Substantially Equivalent | 7D Surgical | accessdata.fda.gov |
| June 21, 2021 | K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | OLO | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| March 23, 2021 | K210555 | 7D Surgical System - Drill Guide | OLO | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| September 3, 2020 | K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array | OLO | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| November 27, 2019 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | HAW | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| November 5, 2019 | K192140 | 7D Surgical System | OLO | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| August 7, 2019 | K183276 | 7D Surgical System | HAW | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| August 8, 2018 | K181041 | 7D Surgical System Cranial Application | HAW | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| May 2, 2018 | K180352 | 7D Surgical System | OLO | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
| December 29, 2016 | K162375 | Envision 3D: Image Guidance System | OLO | Substantially Equivalent | 7D Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.