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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 K173892
Device Name NuVasive® XLX Interbody System
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Cynthia Adams
Correspondent
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Manthan Damani
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
OVD   PHM  
Date Received12/21/2017
Decision Date 05/04/2018
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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