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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 K170021
Device Name SMV Scientific Cannulated Screws
Applicant
Smv Scientific
111 Sandra Muraida Way Unit 18a
Austin,  TX  78703
Applicant Contact Nephi Zufelt
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C. Maxwell
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/03/2017
Decision Date 05/22/2017
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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