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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 Integrated Fixation, Lumbar
510(k) Number K103369
Device Name VAULT ALIF SYSTEM
Applicant
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact LINDA POLK
Correspondent
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Correspondent Contact LINDA POLK
Regulation Number888.3080
Classification Product Code
OVD  
Date Received11/17/2010
Decision Date 04/04/2011
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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