Lumbar Spine Truss System Plating Solution (LSTS-PS)— 510(k) K203065

Substantially Equivalent

4Web, Inc.

FDA 510(k) clearance K203065 for Lumbar Spine Truss System Plating Solution (LSTS-PS), Substantially Equivalent on 2021-03-10. Applicant: 4Web, Inc..

Clearance details

Applicant: 4Web, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2020-10-09
Decision date: 2021-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.