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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 K253718
Device Name enHAnce PEEK Bunion System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Applicant Contact Marisa Zink
Correspondent
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Correspondent Contact Marisa Zink
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/24/2025
Decision Date 04/01/2026
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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