NANOBONE / GRANULATE

Filler, Bone Void, Calcium Compound

ARTOSS GMBH

The following data is part of a premarket notification filed by Artoss Gmbh with the FDA for Nanobone / Granulate.

Pre-market Notification Details

Device IDK141189
510k NumberK141189
Device Name:NANOBONE / GRANULATE
ClassificationFiller, Bone Void, Calcium Compound
Applicant ARTOSS GMBH FRIEDRICH-BARNEWITZ-STR. 3 Rostock,  DE 18119
ContactWalter Gerike
CorrespondentWalter Gerike
ARTOSS GMBH FRIEDRICH-BARNEWITZ-STR. 3 Rostock,  DE 18119
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-08
Decision Date2015-01-30
Summary:summary

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