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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K191169
Device Name NuVasive® Camber Laminoplasty System
Applicant
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Thao Huynh
Correspondent
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Thao Huynh
Regulation Number888.3050
Classification Product Code
NQW  
Date Received05/01/2019
Decision Date 07/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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