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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 K250613
Device Name SnapHammer Hammertoe Correction System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Applicant Contact Erin Lansdale
Correspondent
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Correspondent Contact Erin Lansdale
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/28/2025
Decision Date 04/02/2025
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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