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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, Cervical
510(k) Number K222015
Device Name Integral Titanium Cervical Interbody
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Applicant Contact Diana Langham
Correspondent
Nvision Biomedical Technologies
4590 Lockhill Selma
San Antonio,  TX  78249
Correspondent Contact Analaura Villarreal-Berain
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/08/2022
Decision Date 07/05/2023
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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