ENDURAMESH, MODEL 762.XXX— 510(k) K093207

Clearance details

Applicant

Lucero Medical, LLC

Product code

Product code MQP

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2009-10-13

Decision date

2010-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Richfield, OH, US

• K261810 — Vertiwedge® Intraosseous System2026-07-31
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• K253158 — VyBrate VBR System2026-01-07
• K241468 — Vertiwedge® Intraosseous System2024-11-07
• K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

• K200549 — Lucero Medical Cervical Cage System2020-12-16
• K122622 — ENDURAMESH2012-09-19

Injury

372

Malfunction

519

Total

891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2368-2012 — Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.Class II·Terminated·Lucero Medical LLC·20120715

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093207.