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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 K200922
Device Name Altus Spine HA Pedicle Screw System
Applicant
Altus Partners, LLC
1340 Enterprise Dr.
West Chester,  PA  19380
Applicant Contact Mark Melton
Correspondent
Altus Partners, LLC
1340 Enterprise Dr.
West Chester,  PA  19380
Correspondent Contact Mark Melton
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWQ  
Date Received04/06/2020
Decision Date 01/26/2021
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
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