FDA.reportPublic FDA data

510(k) K223174

Device
X-Pac Expandable LLIF Cage System
Applicant
Expanding Innovations, Inc.
510(k) number
K223174
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-14
Date received
2022-10-11
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Robert Jaramillo
Address
110 Pioneer Way, Suite 1 Mountain View CA US 94041 94041

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K251479Mobarn 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))Mobarn Medical Devices, LLC2025-09-18
K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.2025-09-04