The following data is part of a premarket notification filed by Artoss Gmbh with the FDA for Nanobone Sbx Putty, Nanobone Qd.
| Device ID | K190110 |
| 510k Number | K190110 |
| Device Name: | NanoBone SBX PUTTY, NanoBone QD |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Artoss Gmbh Friedrich-Barnewitz Strasse 3 Rostock, DE 18119 |
| Contact | Walter Gerike |
| Correspondent | Walter Gerike Artoss Gmbh Friedrich-Barnewitz Strasse 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 | 2019-01-23 |
| Decision Date | 2019-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14260418440741 | K190110 | 000 |
| 14260418440734 | K190110 | 000 |
| 14260418440727 | K190110 | 000 |
| 14260418440710 | K190110 | 000 |
| 14260418440703 | K190110 | 000 |
| 14260418440536 | K190110 | 000 |
| 14260418440529 | K190110 | 000 |
| 14260418440512 | K190110 | 000 |
| 14260418440758 | K190110 | 000 |