Z-LINKPC System— 510(k) K162575

Substantially Equivalent

Zavation, LLC

FDA 510(k) clearance K162575 for Z-LINKPC System, Substantially Equivalent on 2017-03-03. Applicant: Zavation, LLC.

Clearance details

Applicant: Zavation, LLC
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2016-09-15
Decision date: 2017-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.