510(k) K253201

Lumbar Spine Truss System - Plating Solution (LSTS-PS) by 4Web, Inc. — Product Code KWQ

K253201 is an FDA 510(k) premarket notification submitted by 4Web, Inc. for the device "Lumbar Spine Truss System - Plating Solution (LSTS-PS)". The FDA issued a decision of Substantially Equivalent on February 12, 2026. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. 4Web, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2026
Date Received
September 26, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type