FDA 510(k)

2D Hip Planning Software

K-Number: K261352 · 2026-06-08

Decision Date2026-06-08

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

2D Hip Planning Software is the device name listed in this FDA 510(k) record. The listed applicant is One Ortho. It received FDA 510(k) clearance on 2026-06-08 under 510(k) number K261352. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2D Hip Planning Software?

2D Hip Planning Software is a medical device that received FDA 510(k) clearance on 2026-06-08. The listed applicant is One Ortho. The 510(k) number is K261352.

When did 2D Hip Planning Software receive FDA 510(k) clearance?

2D Hip Planning Software received FDA 510(k) clearance on 2026-06-08, under 510(k) number K261352.

Who is the listed applicant for 2D Hip Planning Software?

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

What is the FDA product code for 2D Hip Planning Software?

The FDA product code for 2D Hip Planning Software is LLZ.

Related Devices (Code: LLZ)

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.

K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.K260500ResolutionMDResolutionMD, Inc.K262120Avara ViewerAvara Software

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.