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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 K141189
Device Name NANOBONE / GRANULATE
Applicant
ARTOSS GMBH
FRIEDRICH-BARNEWITZ-STR. 3
ROSTOCK,  DE 18119
Applicant Contact WALTER GERIKE
Correspondent
ARTOSS GMBH
FRIEDRICH-BARNEWITZ-STR. 3
ROSTOCK,  DE 18119
Correspondent Contact WALTER GERIKE
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/08/2014
Decision Date 01/30/2015
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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