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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K260291
Device Name Vortex5 Tailor's Bunion Correction System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Applicant Contact Zink Marisa
Correspondent
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Correspondent Contact Zink Marisa
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/29/2026
Decision Date 03/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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