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FDA 510(k)

Knee+

K-Number: K253805 · 2026-04-24

ApplicantPixee Medical S.A.S.
Decision Date2026-04-24
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Knee+ is a medical device manufactured by Pixee Medical S.A.S.. It received FDA 510(k) clearance on 2026-04-24 under approval number K253805. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Knee+?

Knee+ is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Pixee Medical S.A.S.. The 510(k) number is K253805.

When was Knee+ approved by the FDA?

Knee+ received FDA 510(k) clearance on 2026-04-24, under approval number K253805.

What company makes Knee+?

Knee+ is manufactured by Pixee Medical S.A.S..

What is the FDA product code for Knee+?

The FDA product code for Knee+ is SBF.

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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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