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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K150647
Device Name Polyscrew Pedicle Screw System
Applicant
New Era Orthopedics, LLC
1214 Research Blvd., Suite 1019
Hummelstown,  PA  17036
Applicant Contact Mark De Baca
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C Maxwell II
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received03/12/2015
Decision Date 04/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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