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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, Threaded
510(k) Number K182171
Device Name SMV Scientific K-Wire and Pins
Applicant
Summit Medventures
7500 Rialto Blvd., Bldg. 1, Suite 225
Austin,  TX  78738
Applicant Contact Nephi Zufelt
Correspondent
Empirical Consulting, LLC
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HTY  
Date Received08/10/2018
Decision Date 10/25/2018
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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