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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 K162426
Device Name nva, nvp, and nvt
Applicant
Nvision Biomedical Technologies, LLC
1350 N Loop 1604 E, Suite 103
San Antonio,  TX  78232
Applicant Contact Diana L. Langham
Correspondent
Acknowledge Regulatory Strategies
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/30/2016
Decision Date 09/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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