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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 K935593
Device Name ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
Applicant
Biodynamic Technologies, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Biodynamic Technologies, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3690
Classification Product Code
HSD  
Date Received11/19/1993
Decision Date 10/14/1994
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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