FDA.reportPublic FDA data

510(k) K232069

Device
Expandable Lumbar Fusion Cage (Type I,Type II)
Applicant
Shanghai Reach Medical Instrument Co, Ltd.
510(k) number
K232069
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-29
Date received
2023-07-12
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
Jian Shen
Address
Bldg. 13,#999 Jiangyue Rd., Minhang District Shanghai CN 201114 201114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
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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