K251479

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))

510(k) number
K251479
Device name
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 LA · US
Product code
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Decision date
2025-09-18
Date received
2025-05-13
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
510(k) Summary (official FDA PDF): K251479.pdf
Official FDA record: K251479
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.