Tarsa-Link Wedge Fixation System— 510(k) K150368

Substantially Equivalent

Life Spine

FDA 510(k) clearance K150368 for Tarsa-Link Wedge Fixation System, Substantially Equivalent on 2015-03-24. Applicant: Life Spine.

Clearance details

Applicant: Life Spine
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2015-02-12
Decision date: 2015-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Huntley, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.