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FDA 510(k)

Zavation VariSync Plate System and VariSync Spacer System

K-Number: K221049 · 2022-08-12

ApplicantZavation Medical Products, LLC
Decision Date2022-08-12
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation VariSync Plate System and VariSync Spacer System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2022-08-12 under approval number K221049. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zavation VariSync Plate System and VariSync Spacer System?

Zavation VariSync Plate System and VariSync Spacer System is a medical device that received FDA 510(k) clearance on 2022-08-12. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K221049.

When was Zavation VariSync Plate System and VariSync Spacer System approved by the FDA?

Zavation VariSync Plate System and VariSync Spacer System received FDA 510(k) clearance on 2022-08-12, under approval number K221049.

What company makes Zavation VariSync Plate System and VariSync Spacer System?

Zavation VariSync Plate System and VariSync Spacer System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Zavation VariSync Plate System and VariSync Spacer System?

The FDA product code for Zavation VariSync Plate System and VariSync Spacer System is OVE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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