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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K250646
Device Name Impact PEEK Union Nail System
Applicant
Nvision Biomedical Technologies
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Applicant Contact Erin Lansdale
Correspondent
Nvision Biomedical Technologies
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Correspondent Contact Tom Zink
Regulation Number888.3040
Classification Product Code
HTY  
Date Received03/04/2025
Decision Date 06/11/2025
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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