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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K180038
Device Name NuVasive Pulse System
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Olga Lewis
Correspondent
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Olga Lewis
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
ETN   GWF   HAW   IKN   JAA  
LLZ   OWB   PDQ  
Date Received01/05/2018
Decision Date 06/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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