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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 K213654
Device Name NuVasive Reline Cervical System
Applicant
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Sali Gully
Correspondent
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Sali Gully
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received11/19/2021
Decision Date 02/23/2022
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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