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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 the device name listed in this FDA 510(k) record. The listed applicant is Adaptix Limited. It received FDA 510(k) clearance on 2025-11-06 under 510(k) 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. The listed applicant is Adaptix Limited. The 510(k) number is K252133.

When did Adaptix Ortho350 receive FDA 510(k) clearance?

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

Who is the listed applicant for Adaptix Ortho350?

The FDA 510(k) record lists Adaptix Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adaptix Ortho350?

The FDA product code for Adaptix Ortho350 is IZF.

Related Devices (Code: IZF)

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.

K252649TAP2DNano-X Imaging , Ltd.K250850Nanox.ARC XNano-X Imaging , Ltd.K242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbHK213081CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A

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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