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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 K181255
Device Name PRODENSE Bone Graft Substitute
Applicant
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  37117
Applicant Contact Rachel Roberts
Correspondent
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  37117
Correspondent Contact Rachel Roberts
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
FMF  
Date Received05/11/2018
Decision Date 09/12/2018
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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