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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K142980
Device Name Proficient (TM) Facet Screw Spine System
Applicant
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact ROAIDA JOHNSON
Correspondent
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact ROAIDA JOHNSON
Classification Product Code
MRW  
Date Received10/15/2014
Decision Date 01/16/2015
Decision Substantially Equivalent (SESE)
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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