510(k) Report

FDA applicant

Surgalign Spine Technologies

Deerfield, IL3 decisions2022–20232 recalls

FDA records 3 decisions for Surgalign Spine Technologies (Deerfield, IL) from 2022 to 2023: 3 510(k) clearances. Most are in product codes SBF (Orthopedic Augmented Reality) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

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 Surgalign Spine Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 22023: 1
2022high 2 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2024

2023: 12024: 1
2022high 1 (2023) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Surgalign Spine Technologies by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • SBFOrthopedic Augmented Reality2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies · 20221cites it
  • K211254ARAI Surgical Navigation SystemSurgalign Spine Technologies · 20221cites it

What has FDA decided for it lately?

  • K231611HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies · 2023
  • K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies · 20222 recalls
  • K211254ARAI Surgical Navigation SystemSurgalign Spine Technologies · 2022

All 3 as Surgalign Spine Technologies →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K221403Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045Aug 21, 2024Class II
  • K221403Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5…Nov 28, 2023Class II