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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement, Posterior Screw Augmentation
510(k) Number K260286
Device Name Dynamo™ Spinal Cement; Salvo® Spine System
Applicant
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact Ronald Smith
Correspondent
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact Ronald Smith
Regulation Number888.3027
Classification Product Code
PML  
Subsequent Product Code
NKB  
Date Received01/29/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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