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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K192181
Device Name PRECICE Plating System
Applicant
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Applicant Contact Madison Heffron
Correspondent
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Correspondent Contact Madison Heffron
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
HRS   HWC  
Date Received08/12/2019
Decision Date 11/07/2019
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
Recalls CDRH Recalls
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