The FDA on June 9 granted orthopedic device company 4WEB Medical 510(k) clearance for its Stand-Alone Anterior Lumbar Interbody Fusion Device.
Three things to know:
1. The implant is designed with single-step locking mechanisms and will be available in various footprints, lordotic angles and heights.
2. The device does not require supplemental fixation when used with screws.
3. 4WEB Medical has received two 510(k) clearances this year, and plans to launch a lateral lumbar implant later in 2020.