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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 K201567
Device Name Precice® Bone Transport 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 Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received06/11/2020
Decision Date 08/10/2020
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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