Freedom DS Decompression System— 510(k) K253523
Substantially EquivalentSpinal Simplicity
FDA 510(k) clearance K253523 for Freedom DS Decompression System, Substantially Equivalent on 2026-04-16. Applicant: Spinal Simplicity. Device class: 2.
Summary
Spinal Simplicity's Freedom DS Decompression System is filed under product code HRX (Arthroscope). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.1100. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Spinal Simplicity filed from Overland Park, Kansas. The record shows 154 calendar days from receipt to decision (November 13, 2025 to April 16, 2026).
Clearance details
- Applicant
- Spinal Simplicity
- Product code
- Product code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
Recent devices under product code HRX
view allMore clearances from Spinal Simplicity
view allAdverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.