LDR SPINE ROI-A IMPLANT— 510(k) K080572

Substantially Equivalent

Ldr Spine USA

FDA 510(k) clearance K080572 for LDR SPINE ROI-A IMPLANT, Substantially Equivalent on 2008-04-07. Applicant: Ldr Spine USA.

Clearance details

Applicant: Ldr Spine USA
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2008-02-29
Decision date: 2008-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.