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FDA 510(k)

Zaga Zygomatic System

K-Number: K222497 · 2022-11-09

Decision Date2022-11-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zaga Zygomatic System is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2022-11-09 under 510(k) number K222497. 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 2022-11-09. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K222497.

When did Zaga Zygomatic System receive FDA 510(k) clearance?

Zaga Zygomatic System received FDA 510(k) clearance on 2022-11-09, under 510(k) number K222497.

Who is the listed applicant for Zaga Zygomatic System?

The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zaga Zygomatic System?

The FDA product code for Zaga Zygomatic System is DZE.

Other records listing Southern Implants (Pty), Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 19 devices →

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.