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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 K172175
Device Name CapSure® PS System
Applicant
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact Amy Noccioli
Correspondent
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact Amy Noccioli
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/19/2017
Decision Date 08/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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