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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 K160946
Device Name 4.0 and 6.5 Cancellous Bone Screw and Washer
Applicant
SMV SCIENTIFIC
111 SANDRA MURAIDA WAY UNIT 18A
AUSTIN,  TX  78703
Applicant Contact Nephi Zufelt
Correspondent
EMPIRICAL TESTING CORP.
4628 NORTHPARK DRIVE
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C. Maxwell II
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received04/05/2016
Decision Date 12/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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