The following data is part of a premarket notification filed by Kuros Biosciences B.v. with the FDA for Magnetos Easypack Putty.
| Device ID | K211201 |
| 510k Number | K211201 |
| Device Name: | MagnetOs Easypack Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Kuros Biosciences B.V. Professor Bronkhorstlaan 10, Building 48 Bilthoven, NL 3723mb |
| Contact | Marcel Borger |
| Correspondent | Angela Paterson Compliance Solutions Ltd Suite 10, Dunswood House, 1 Dunswood Road, Cumbernauld Glasgow, GB G67 3en |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-22 |
| Decision Date | 2021-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719699712157 | K211201 | 000 |
| 08719699712140 | K211201 | 000 |
| 08719699712133 | K211201 | 000 |
| 08719699712126 | K211201 | 000 |
| 08719699712119 | K211201 | 000 |
| 08719699712102 | K211201 | 000 |
| 08719699712096 | K211201 | 000 |
| 08719699712089 | K211201 | 000 |
| 08719699712072 | K211201 | 000 |