510(k) Report

FDA applicant

7D Surgical, Inc.

Toronto, CA10 decisions2016–20220 recalls

FDA records 10 decisions for 7D Surgical, Inc. (Toronto, CA) from 2016 to 2022: 10 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and HAW (Neurological Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “7D Surgical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided 7D Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12018: 22019: 32020: 12021: 22022: 1
2016high 3 (2019) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — 7D Surgical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 7D Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument7decisions
  • HAWNeurological Stereotaxic Instrument3decisions

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 7 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1803527D Surgical System7D Surgical, Inc. · 20185cite it
  • K162375Envision 3D: Image Guidance System7D Surgical, Inc. · 20165cite it
  • K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. · 20192cite it
  • K1921407D Surgical System7D Surgical, Inc. · 20192cite it
  • K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac…7D Surgical, Inc. · 20211cites it
  • K1810417D Surgical System Cranial Application7D Surgical, Inc. · 20181cites it

What has FDA decided for it lately?

  • K2205227D Surgical System - Percutaneous Application (7D Flash Frame)7D Surgical · 2022
  • K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac…7D Surgical, Inc. · 2021
  • K2105557D Surgical System - Drill Guide7D Surgical, Inc. · 2021
  • K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array7D Surgical, Inc. · 2020
  • K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. · 2019
  • K1921407D Surgical System7D Surgical, Inc. · 2019
  • K1832767D Surgical System7D Surgical, Inc. · 2019
  • K1810417D Surgical System Cranial Application7D Surgical, Inc. · 2018

All 9 as 7D Surgical, Inc. →The one decision as 7D Surgical →