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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 K151648
Device Name Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
Applicant
Altus Partners, LLC
5129 W. Chester Pike
Newtown Square,  PA  19073
Applicant Contact Claudia Hill
Correspondent
Altus Partners, LLC
5129 W. Chester Pike
Newtown Square,  PA  19073
Correspondent Contact Claudia Hill
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received06/18/2015
Decision Date 10/16/2015
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
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