The following data is part of a premarket notification filed by Kuros Biosciences B.v. with the FDA for Magnetos Putty.
Device ID | K171563 |
510k Number | K171563 |
Device Name: | MagnetOs Putty |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | Kuros Biosciences B.V. Professor Bronkhorstlaan 10, Building 48 Bilthoven, NL 3723mb |
Contact | Yvonne P. Bovell |
Correspondent | Yvonne P. Bovell Kuros Biosciences B.V. Professor Bronkhorstlaan 10, Building 48 Bilthoven, NL 3723mb |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-30 |
Decision Date | 2017-08-24 |
Summary: | summary |