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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 K163487
Device Name Ultima HA Coated Half Pins and Wire
Applicant
Vilex IN Tennessee, Inc.
111 Moffitt St.
Mcminnville,  TN  37110
Applicant Contact Sylvia Southard
Correspondent
Vilex, Inc.
8374 Market St., #167
Lakewood Ranch,  FL  34202
Correspondent Contact Abraham Lavi
Regulation Number888.3040
Classification Product Code
JDW  
Date Received12/12/2016
Decision Date 02/13/2017
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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