The following data is part of a premarket notification filed by Artoss Gmbh with the FDA for Nanobone / Granulate.
| Device ID | K141189 |
| 510k Number | K141189 |
| Device Name: | NANOBONE / GRANULATE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ARTOSS GMBH FRIEDRICH-BARNEWITZ-STR. 3 Rostock, DE 18119 |
| Contact | Walter Gerike |
| Correspondent | Walter Gerike ARTOSS GMBH FRIEDRICH-BARNEWITZ-STR. 3 Rostock, DE 18119 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-08 |
| Decision Date | 2015-01-30 |
| Summary: | summary |