510(k) Report

FDA applicant

Lucero Medical, LLC

Richfield, OH3 decisions2010–20201 recall

FDA records 3 decisions for Lucero Medical, LLC (Richfield, OH) from 2010 to 2020: 3 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 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 Lucero Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 12012: 12020: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2010high 1 (2012) · low 0 (2010)2026

Class I Class II/III not classified

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

Planning a device like Lucero Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MQPSpinal Vertebral Body Replacement Device2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K093207Enduramesh, Model 762.XXXLucero Medical, LLC · 20101cites it

What has FDA decided for it lately?

  • K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC · 2020
  • K122622EndurameshLucero Medical, LLC · 2012
  • K093207Enduramesh, Model 762.XXXLucero Medical, LLC · 20101 recall

All 3 as Lucero Medical, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K093207Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body…Jul 15, 2012Class II