EASYSPINE SYSTEM— 510(k) K043094

Substantially Equivalent

Ldr Spine USA

FDA 510(k) clearance K043094 for EASYSPINE SYSTEM, Substantially Equivalent on 2005-02-11. Applicant: Ldr Spine USA.

Clearance details

Applicant: Ldr Spine USA
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2004-11-09
Decision date: 2005-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.