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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 K142576
Device Name Spinal System
Applicant
EISERTECH, LLC
13795 Blaisdell Place, Suite 102
Poway,  CA  92064
Applicant Contact Lukas Eisermann
Correspondent
EISERTECH, LLC
13795 Blaisdell Place, Suite 102
Poway,  CA  92064
Correspondent Contact Lukas Eisermann
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received09/12/2014
Decision Date 02/26/2015
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
Recalls CDRH Recalls
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