Lumbar Spine Truss System - Plating Solution (LSTS-PS)— 510(k) K253201
Substantially Equivalent4Web, Inc.
FDA 510(k) clearance K253201 for Lumbar Spine Truss System - Plating Solution (LSTS-PS), Substantially Equivalent on 2026-02-12. Applicant: 4Web, Inc.. Device class: 2.
Summary
4Web's Lumbar Spine Truss System - Plating Solution (LSTS-PS) is filed under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
4Web filed from Frisco, Texas. The substantially equivalent decision came 139 calendar days after receipt (September 26, 2025 to February 12, 2026).
Clearance details
- Applicant
- 4Web, Inc.
- Product code
- Product code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Frisco, TX, US
Recent devices under product code KWQ
view allMore clearances from 4Web, Inc.
view allAdverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.