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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 K190290
Device Name AltiVate Reverse Humeral Stem, 48mm
Applicant
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact Teffany Hutto
Correspondent
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Teffany Hutto
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received02/11/2019
Decision Date 04/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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