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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 K180503
Device Name PRECICE STRYDE System
Applicant
NuVasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Aliso Viejo,  CA  92656
Applicant Contact Lance Justice
Correspondent
NuVasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact Lance Justice
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received02/26/2018
Decision Date 04/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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