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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 K161842
Device Name Overwatch Spine System
Applicant
Amendia, Inc.
1755 W. Oak Pkwy.
Marietta,  GA  30062
Applicant Contact Bruce Hooper
Correspondent
Amendia, Inc.
1755 W. Oak Pkwy.
Marietta,  GA  30062
Correspondent Contact Chelsea Proffitt
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received07/05/2016
Decision Date 10/13/2016
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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