K100575

Substantially Equivalent

LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

Applicant: Ldr Spine USA
Product code: MNI
Advisory panel: Orthopedic
Date received: 2010-03-01
Decision date: 2010-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

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.