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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 K003324
Device Name PLASMA SPRAYED SHOULDER
Applicant
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact JOANNA DROEGE
Correspondent
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact JOANNA DROEGE
Regulation Number888.3660
Classification Product Code
KWS  
Date Received10/24/2000
Decision Date 12/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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