FDA 510(k)

Freedom DS Decompression System

K-Number: K253523 · 2026-04-16

Decision Date2026-04-16

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Freedom DS Decompression System is a medical device manufactured by Spinal Simplicity. It received FDA 510(k) clearance on 2026-04-16 under approval number K253523. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freedom DS Decompression System?

Freedom DS Decompression System is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Spinal Simplicity. The 510(k) number is K253523.

When was Freedom DS Decompression System approved by the FDA?

Freedom DS Decompression System received FDA 510(k) clearance on 2026-04-16, under approval number K253523.

What company makes Freedom DS Decompression System?

Freedom DS Decompression System is manufactured by Spinal Simplicity.

What is the FDA product code for Freedom DS Decompression System?

The FDA product code for Freedom DS Decompression System is HRX.

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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.