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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, Semi-Constrained, Cemented
510(k) Number K960087
Device Name SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
Applicant
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact JUDY ENGLISH
Correspondent
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact JUDY ENGLISH
Regulation Number888.3160
Classification Product Code
JDB  
Date Received01/11/1996
Decision Date 09/20/1996
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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