Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)) +3 more— 510(k) K251479

Name: FDA 510(k) clearance K251479
Creator: U.S. Food and Drug Administration
Published: 2025-09-18

Substantially Equivalent

Mobarn Medical Devices, LLC

FDA 510(k) clearance K251479 for Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)) +3 more, Substantially Equivalent on 2025-09-18. Applicant: Mobarn Medical Devices, LLC. Device class: 2.

Clearance details

Device name as filed: Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))
Applicant: Mobarn Medical Devices, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-05-13
Decision date: 2025-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Orleans, LA, US

Download summary PDF View on FDA.gov ↗

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.