ELID (Endoscopic Less Invasive Decompression) System— 510(k) K243774

Substantially Equivalent

Lesspine Innovations

FDA 510(k) clearance K243774 for ELID (Endoscopic Less Invasive Decompression) System, Substantially Equivalent on 2025-08-27. Applicant: Lesspine Innovations.

Clearance details

Applicant: Lesspine Innovations
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2024-12-06
Decision date: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.