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FDA 510(k)

xStep (xStep)

K-Number: K253638 · 2026-04-20

ApplicantSpinex, Inc.
Decision Date2026-04-20
Product CodeSDO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

xStep (xStep) is a medical device manufactured by Spinex, Inc.. It received FDA 510(k) clearance on 2026-04-20 under approval number K253638. The device is classified under product code SDO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xStep (xStep)?

xStep (xStep) is a medical device that received FDA 510(k) clearance on 2026-04-20. It is manufactured by Spinex, Inc.. The 510(k) number is K253638.

When was xStep (xStep) approved by the FDA?

xStep (xStep) received FDA 510(k) clearance on 2026-04-20, under approval number K253638.

What company makes xStep (xStep)?

xStep (xStep) is manufactured by Spinex, Inc..

What is the FDA product code for xStep (xStep)?

The FDA product code for xStep (xStep) is SDO.

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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.

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