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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K162024
Device Name AltiVate Anatomic Shoulder System
Applicant
ENCORE MEDICAL, L.P
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact DESIREE WELLS
Correspondent
ENCORE MEDICAL, L.P
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact DESIREE WELLS
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   PAO  
Date Received07/22/2016
Decision Date 11/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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