K253523

Freedom DS™ Decompression System

510(k) number
K253523
Device name
Freedom DS™ Decompression System
Applicant
Spinal Simplicity KS · US
Product code
HRX — Arthroscope
Decision date
2026-04-16
Date received
2025-11-13
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K253523.pdf

Official FDA record: K253523
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.