The following data is part of a premarket notification filed by Kuros Biosciences B.v. with the FDA for Magnetos Putty.
| Device ID | K181958 |
| 510k Number | K181958 |
| Device Name: | MagnetOs Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Kuros Biosciences B.V. Professor Bronkhorstlaan 10, Building 48 Bilthoven, NL 3723 Mb |
| Contact | Yvonne P. Bovell |
| 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 | 2018-07-23 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981180539 | K181958 | 000 |
| 10889981180522 | K181958 | 000 |
| 10889981180515 | K181958 | 000 |
| 10889981180508 | K181958 | 000 |
| 10889981180492 | K181958 | 000 |
| 10889981180485 | K181958 | 000 |
| 10889981180478 | K181958 | 000 |
| 10889981180461 | K181958 | 000 |