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FDA 510(k)

Freedom DS™ Decompression System

K-Number: K253523 · 2026-04-16

ApplicantSpinal Simplicity
Decision Date2026-04-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom DS™ Decompression System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity. It received FDA 510(k) clearance on 2026-04-16 under 510(k) 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. The listed applicant is Spinal Simplicity. The 510(k) number is K253523.

When did Freedom DS™ Decompression System receive FDA 510(k) clearance?

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

Who is the listed applicant for Freedom DS™ Decompression System?

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

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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Related Devices (Code: HRX)

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.

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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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