510(k) Report

FDA applicant

NanoHive Medical, LLC

Woburn, MA3 decisions2022–20260 recalls

FDA records 3 decisions for NanoHive Medical, LLC (Woburn, MA) from 2022 to 2026: 3 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OVE (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 1 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 NanoHive Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like NanoHive Medical, LLC’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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 60 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 117 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 15 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.

  • K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 20222cite it

What has FDA decided for it lately?

  • K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC · 2026
  • K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC · 2023
  • K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022

All 3 as NanoHive Medical, LLC →