510(k) Report

FDA applicant

Blustone Synergy, LLC

Pueblo, CO3 decisions2017–20210 recalls

FDA records 3 decisions for Blustone Synergy, LLC (Pueblo, CO) from 2017 to 2021: 3 510(k) clearances. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 141 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Blustone Synergy”.

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 Blustone Synergy, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2017: 12021: 2
2017high 2 (2021) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Blustone Synergy, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MQPSpinal Vertebral Body Replacement Device1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 141 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021
  • K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC · 2021
  • K172330Blustone Synergy Silica SystemBlustone Synergy · 2017

All 2 as Blustone Synergy, LLC →The one decision as Blustone Synergy →