The following data is part of a premarket notification filed by Kuros Biosciences Bv with the FDA for Magnetos Flex Matrix.
| Device ID | K213959 |
| 510k Number | K213959 |
| Device Name: | MagnetOs Flex Matrix |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Kuros Biosciences BV Professor Bronkhorstlaan 10, Building 48 Bilthoven, NL 3723 Mb |
| Contact | Sonja Van Der Meer |
| Correspondent | Sonja Van Der Meer Kuros Biosciences BV Professor Bronkhorstlaan 10, Building 48 Bilthoven, NL 3723 Mb |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719699712195 | K213959 | 000 |
| 08719699712188 | K213959 | 000 |
| 08719699712171 | K213959 | 000 |
| 08719699712164 | K213959 | 000 |