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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 K191336
Device Name PRECICE System
Applicant
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Applicant Contact Aditya Sharma
Correspondent
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Correspondent Contact Aditya Sharma
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received05/17/2019
Decision Date 09/26/2019
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
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