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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K032686
Device Name ASCENSION MODULAR RADIAL HEAD
Applicant
Ascension Orthopedics, Inc.
8200 Cameron Rd., Suite C-140
Austin,  TX  78754 -3832
Applicant Contact PETER STRZEPA
Correspondent
Ascension Orthopedics, Inc.
8200 Cameron Rd., Suite C-140
Austin,  TX  78754 -3832
Correspondent Contact PETER STRZEPA
Regulation Number888.3170
Classification Product Code
KWI  
Date Received08/29/2003
Decision Date 10/22/2003
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
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