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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K072367
Device Name REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
Applicant
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact EHAB M ESMAIL
Correspondent
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact EHAB M ESMAIL
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Code
JDI  
Date Received08/23/2007
Decision Date 01/09/2008
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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