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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K193541
Device Name NuVasive Cohere Thoracolumbar Interbody System
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Michelle Cheung
Correspondent
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Michelle Cheung
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
PHM  
Date Received12/20/2019
Decision Date 03/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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