510(k) Report

FDA applicant

Incite Innovation, LLC

Springfield, MA4 decisions2010–20150 recalls

FDA records 4 decisions for Incite Innovation, LLC (Springfield, MA) from 2010 to 2015: 4 510(k) clearances. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and OVD (Intervertebral Fusion Device With Integrated…). Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Incite Innovation”.

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 Incite Innovation, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010: 12012: 12013: 12015: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Incite Innovation, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Incite Innovation, 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?

  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical3decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC · 20123cite it
  • K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC · 20101cites it
  • K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC · 20131cites it

What has FDA decided for it lately?

  • K150913Incite Anchored Cervical Interbody DeviceIncite Innovation · 2015
  • K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC · 2013
  • K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC · 2012
  • K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC · 2010

All 3 as Incite Innovation, LLC →The one decision as Incite Innovation →