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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 Non-Fusion Spinous Process Spacer Devices
510(k) Number K253118
Device Name Companion Spine DIAM™ Instrumentation
Applicant
Companion Spine France
5 Allée Des Acacias
Mérignac,  FR 33700
Applicant Contact Nazanine Cloix
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Lucas Tatem
Classification Product Code
QLR  
Date Received09/24/2025
Decision Date 12/16/2025
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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