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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K253523
Device Name Freedom DS™ Decompression System
Applicant
Spinal Simplicity
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Applicant Contact Adam Rogers
Correspondent
Spinal Simplicity
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Correspondent Contact Adam Rogers
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HAE  
Date Received11/13/2025
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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