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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 K123982
Device Name TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
Applicant
Encore Medical L.P.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact MICHAELA NORRIS
Correspondent
Encore Medical L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact MICHAELA NORRIS
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
PAO  
Date Received12/26/2012
Decision Date 01/23/2013
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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