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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 K112069
Device Name RSP GLENOID BASEPLATE POROUS COATED
Applicant
Encore Medical L.P.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact WILLIAM GARZON
Correspondent
Encore Medical L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact WILLIAM GARZON
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received07/20/2011
Decision Date 11/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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