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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K182954
Device Name Salvo™ Spine System
Applicant
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact Amy Noccioli
Correspondent
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact Amy Noccioli
Regulation Number888.3070
Classification Product Code
NKB  
Date Received10/24/2018
Decision Date 12/12/2018
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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