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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 K192760
Device Name NuVasive Modulus XLIF Interbody System
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 Jessica LeBlanc
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
OVD   PHM  
Date Received09/30/2019
Decision Date 10/18/2019
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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