FDA.report

510(k) K250186

Device
GoLIF! Lumbar Interbody Fusion System
Applicant
Getset Surgical, SA
510(k) number
K250186
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-21
Date received
2025-01-22
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

Related Records

Applicant Contact

Contact
Jowita Sokalska
Address
Rte. De La Corniche 4 Epalinges Vaud CH 1066 1066

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07640387660850GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660843GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660409GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660393GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660386GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660379GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660362GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660355GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660348GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660331GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660324GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660317GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660300GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660294GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660287GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01
07640387660270GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA2025-04-01

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K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24
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