FDA 510(k)

ZAGA Zygomatic System

K-Number: K192651 · 2020-05-07

Decision Date2020-05-07

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZAGA Zygomatic System is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2020-05-07 under approval number K192651. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAGA Zygomatic System?

ZAGA Zygomatic System is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K192651.

When was ZAGA Zygomatic System approved by the FDA?

ZAGA Zygomatic System received FDA 510(k) clearance on 2020-05-07, under approval number K192651.

What company makes ZAGA Zygomatic System?

ZAGA Zygomatic System is manufactured by Southern Implants (Pty), Ltd..

What is the FDA product code for ZAGA Zygomatic System?

The FDA product code for ZAGA Zygomatic System is DZE.

Other Devices by Southern Implants (Pty), Ltd.

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Related Devices (Code: DZE)

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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.