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FDA 510(k)

ZAFIRA®

K-Number: K254245 · 2026-03-03

ApplicantNew Stetic, SA
Decision Date2026-03-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZAFIRA® is a medical device manufactured by New Stetic, SA. It received FDA 510(k) clearance on 2026-03-03 under approval number K254245. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAFIRA®?

ZAFIRA® is a medical device that received FDA 510(k) clearance on 2026-03-03. It is manufactured by New Stetic, SA. The 510(k) number is K254245.

When was ZAFIRA® approved by the FDA?

ZAFIRA® received FDA 510(k) clearance on 2026-03-03, under approval number K254245.

What company makes ZAFIRA®?

ZAFIRA® is manufactured by New Stetic, SA.

What is the FDA product code for ZAFIRA®?

The FDA product code for ZAFIRA® is EBF.

Other Devices by New Stetic, SA

K192153Portux CAD/CAM Disc

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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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