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FDA 510(k)

Adaptix Ortho350

K-Number: K252133 · 2025-11-06

ApplicantAdaptix Limited
Decision Date2025-11-06
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Adaptix Ortho350 is a medical device manufactured by Adaptix Limited. It received FDA 510(k) clearance on 2025-11-06 under approval number K252133. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Adaptix Ortho350?

Adaptix Ortho350 is a medical device that received FDA 510(k) clearance on 2025-11-06. It is manufactured by Adaptix Limited. The 510(k) number is K252133.

When was Adaptix Ortho350 approved by the FDA?

Adaptix Ortho350 received FDA 510(k) clearance on 2025-11-06, under approval number K252133.

What company makes Adaptix Ortho350?

Adaptix Ortho350 is manufactured by Adaptix Limited.

What is the FDA product code for Adaptix Ortho350?

The FDA product code for Adaptix Ortho350 is IZF.

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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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