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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, Hemi-, Humeral, Metallic Uncemented
510(k) Number K950594
Device Name HEMI-SHOULDER PROSTHESIS
Applicant
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Applicant Contact J. D WEBB
Correspondent
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Correspondent Contact J. D WEBB
Regulation Number888.3690
Classification Product Code
HSD  
Date Received02/09/1995
Decision Date 05/22/1995
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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