Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HipGuide (V 1.0.0.0)

K-Number: K260321 · 2026-05-08

ApplicantOrthopedic Driven Imaging, LLC
Decision Date2026-05-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HipGuide (V 1.0.0.0) is a medical device manufactured by Orthopedic Driven Imaging, LLC. It received FDA 510(k) clearance on 2026-05-08 under approval number K260321. 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 HipGuide (V 1.0.0.0)?

HipGuide (V 1.0.0.0) is a medical device that received FDA 510(k) clearance on 2026-05-08. It is manufactured by Orthopedic Driven Imaging, LLC. The 510(k) number is K260321.

When was HipGuide (V 1.0.0.0) approved by the FDA?

HipGuide (V 1.0.0.0) received FDA 510(k) clearance on 2026-05-08, under approval number K260321.

What company makes HipGuide (V 1.0.0.0)?

HipGuide (V 1.0.0.0) is manufactured by Orthopedic Driven Imaging, LLC.

What is the FDA product code for HipGuide (V 1.0.0.0)?

The FDA product code for HipGuide (V 1.0.0.0) is LLZ.

Related Devices (Code: LLZ)

K254013SubtleHD-PET (1.x)Subtle Medical, Inc. K260716NeowiseCefla S.C.

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.

↑