Zaga Zygomatic System
K-Number: K222497 · 2022-11-09
ApplicantSouthern Implants (Pty), Ltd.
Decision Date2022-11-09
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 2022-11-09 under approval 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. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K222497.
When was Zaga Zygomatic System approved by the FDA?
Zaga Zygomatic System received FDA 510(k) clearance on 2022-11-09, under approval number K222497.
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.
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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.