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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K172497
Device Name NuVasive AttraX Scaffold
Applicant
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Marysa E. Loustalot
Correspondent
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Martin Yahiro, MD
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/18/2017
Decision Date 11/24/2017
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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