FDA 510(k)

SkeletonPlanner

K-Number: K260206 · 2026-07-15

Decision Date2026-07-15

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SkeletonPlanner is the device name listed in this FDA 510(k) record. The listed applicant is UPlanner B.V. - Presurgeo. It received FDA 510(k) clearance on 2026-07-15 under 510(k) number K260206. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SkeletonPlanner?

SkeletonPlanner is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is UPlanner B.V. - Presurgeo. The 510(k) number is K260206.

When did SkeletonPlanner receive FDA 510(k) clearance?

SkeletonPlanner received FDA 510(k) clearance on 2026-07-15, under 510(k) number K260206.

Who is the listed applicant for SkeletonPlanner?

The FDA 510(k) record lists UPlanner B.V. - Presurgeo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkeletonPlanner?

The FDA product code for SkeletonPlanner is QIH.

Related Devices (Code: QIH)

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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.