The following data is part of a premarket notification filed by Reoss Gmbh with the FDA for Yxoss Cbr®.
| Device ID | K192747 |
| 510k Number | K192747 |
| Device Name: | Yxoss CBR® |
| Classification | Plate, Bone |
| Applicant | ReOss GmbH Talstrasse 23 Filderstadt, DE 70794 |
| Contact | Michael Peetz |
| Correspondent | Viky Verna confinis 15807 Glacier Court North Potomac, MD 20878 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251880700009 | K192747 | 000 |