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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K024336
Device Name MIIG II BONE GRAFT SUBSTITUTE
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 Number888.3045
Classification Product Code
MQV  
Date Received12/27/2002
Decision Date 03/04/2003
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
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