510(k) Report

FDA applicant

Happe Spine

Grand Rapids, MI1 decision2023–20230 recalls

FDA records 1 decision for Happe Spine (Grand Rapids, MI) in 2023: 1 510(k) clearance. All are in product code ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 3 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 Happe Spine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Happe Spine by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Happe Spine’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?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 20232cite it

What has FDA decided for it lately?

  • K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023

The one decision as Happe Spine →