FDA 510(k)

HipStudio Analysis

K-Number: K262442 · 2026-09-22

Decision Date2026-09-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HipStudio Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Replasia BV. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K262442. 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 HipStudio Analysis?

HipStudio Analysis is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Replasia BV. The 510(k) number is K262442.

When did HipStudio Analysis receive FDA 510(k) clearance?

HipStudio Analysis received FDA 510(k) clearance on 2026-09-22, under 510(k) number K262442.

Who is the listed applicant for HipStudio Analysis?

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

What is the FDA product code for HipStudio Analysis?

The FDA product code for HipStudio Analysis is LLZ.

Related Clinical Trials

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.

NCT07072832Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip DysplasiaACTIVE_NOT_RECRUITING

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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.