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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K173073
Device Name AltiVate Anatomic to Reverse Conversion Module
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
PHX  
Subsequent Product Codes
KWS   PAO  
Date Received09/29/2017
Decision Date 12/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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