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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K170108
Device Name Xultan 5.5 Pedicle Screw System
Applicant
Met One Technologies
154 N. Festival Dr., Suite F
El Paso,  TX  79912
Applicant Contact Dan Gerbec
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C. Maxwell II
Regulation Number888.3070
Classification Product Code
NKB  
Date Received01/12/2017
Decision Date 05/02/2017
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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