Z-Span Plate System— 510(k) K160362

Name: FDA 510(k) clearance K160362
Creator: U.S. Food and Drug Administration
Published: 2016-03-22

Substantially Equivalent

Zavation, LLC

FDA 510(k) clearance K160362 for Z-Span Plate System, Substantially Equivalent on 2016-03-22. Applicant: Zavation, LLC. Device class: 2.

Clearance details

Applicant: Zavation, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2016-02-09
Decision date: 2016-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

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K161016 — Z-Clamp ISP System2016-10-19
K153404 — Zavation Spinal System2016-04-21

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.