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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 K203714
Device Name NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasi
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Jessica LeBlanc
Correspondent
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Martin Yahiro
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQV   OVD   PHM  
Date Received12/21/2020
Decision Date 12/23/2021
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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