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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
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