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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 K153152
Device Name Syzygy Stabilization System
Applicant
Amendia, Inc.
1755 W. Oak Pkwy.
Marietta,  GA  30062
Applicant Contact Kristen Allen
Correspondent
Amendia, Inc.
1755 W. Oak Pkwy.
Marietta,  GA  30062
Correspondent Contact Kristen Allen
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received11/02/2015
Decision Date 04/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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