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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 K190814
Device Name AccuFill Bone Substitute Material
Applicant
Zimmer Knee Creations
841 Springdale Dr.
Exton,  PA  19341
Applicant Contact David l. Nichols
Correspondent
Mcra, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
FMF  
Date Received03/29/2019
Decision Date 06/10/2019
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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