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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 K261961
Device Name Ntegrate Threaded Nail System
Applicant
Nvision Biomedical Technologies
12449 Silicon Dr.
San Antonio,  TX  78249
Applicant Contact Marisa Zink
Correspondent
Nvision Biomedical Technologies
12449 Silicon Dr.
San Antonio,  TX  78249
Correspondent Contact Marisa Zink
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/11/2026
Decision Date 10/14/2026
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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