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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 K060731
Device Name EVOLVE MODULAR RADIAL HEAD
Applicant
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact WESLEY L REED
Correspondent
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact WESLEY L REED
Regulation Number888.3170
Classification Product Code
KWI  
Date Received03/20/2006
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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