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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K213421
Device Name Vector® Hammertoe Correction System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Applicant Contact Diana Langham
Correspondent
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Correspondent Contact Analaura Villarreal-Berain
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/20/2021
Decision Date 11/19/2021
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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