Zavation VariSync Plate System and VariSync Spacer System— 510(k) K221049

Name: FDA 510(k) clearance K221049
Creator: U.S. Food and Drug Administration
Published: 2022-08-12

Substantially Equivalent

Zavation Medical Products, LLC

FDA 510(k) clearance K221049 for Zavation VariSync Plate System and VariSync Spacer System, Substantially Equivalent on 2022-08-12. Applicant: Zavation Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Zavation Medical Products, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-04-11
Decision date: 2022-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

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K253943 — Tiger 2 System2026-07-24
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K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System2024-04-10
K231811 — Zavation Connector System2023-08-22
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Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.