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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K173129
Device Name PRECICE System
Applicant
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Applicant Contact Lance Justice
Correspondent
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Correspondent Contact Lance Justice
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received09/29/2017
Decision Date 12/01/2017
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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