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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Instruments Designed For Use With Total Disc Replacement Devices
510(k) Number K253392
Device Name Synergy Disc Instruments
Applicant
Synergy Spine Solutions, Inc.
357 S. Mccaslin Blvd., Suite 120
Louisville,  CO  80027
Applicant Contact Josh Butters
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Veronica Downen
Classification Product Code
QLQ  
Date Received09/30/2025
Decision Date 03/27/2026
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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