510(k) Report

FDA applicant

Legend Spine Technologies

Bethlehem, PA2 decisions2018–20190 recalls

FDA records 2 decisions for Legend Spine Technologies (Bethlehem, PA) from 2018 to 2019: 2 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

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

How often FDA has decided Legend Spine Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Legend Spine Technologies by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K192208CORNICE Cervical Spacer SystemLegend Spine Technologies · 2019
  • K180071STYLO Interbody Fusion DeviceLegend Spine Technologies · 2018

All 2 as Legend Spine Technologies →