Devices · GetSet Surgical, SA

GoLIF! Lumbar Interbody Fusion System

GetSet Surgical, SA is listed for GoLIF! Lumbar Interbody Fusion System (K250186). The FDA list gives March 21, 2025 as the date of the final decision. The lead panel is Orthopedic, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code MAX as “Intervertebral Fusion Device With Bone Graft, Lumbar”: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250186

Official FDA database record

Date of final decision

March 21, 2025

Company on the FDA list

GetSet Surgical, SA

Lead panel

Orthopedic

Primary product code

MAX

openFDA device name for the code

Intervertebral Fusion Device With Bone Graft, Lumbar

Device class

2

Regulation number

888.3080

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary