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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior cervical screw system
510(k) Number K191553
Device Name NuVaisve® Reline® Cervical System
Applicant
NuVasive, Incorporated
7475 Lusk Boulevard
San Diego,  CA  92121
Applicant Contact Michelle Cheung
Correspondent
NuVasive, Incorporated
7475 Lusk Boulevard
San Diego,  CA  92121
Correspondent Contact Michelle Cheung
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received06/12/2019
Decision Date 08/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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