The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Kainos+.
| Device ID | K090387 |
| 510k Number | K090387 |
| Device Name: | KAINOS+ |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH 8202 SHERMAN ROAD Chseterland, OH 44026 |
| Contact | Karen Warden |
| Correspondent | Karen Warden SIGNUS MEDIZINTECHNIK GMBH 8202 SHERMAN ROAD Chseterland, OH 44026 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04047844023747 | K090387 | 000 |
| 04047844005675 | K090387 | 000 |
| 04047844005682 | K090387 | 000 |
| 04047844005699 | K090387 | 000 |
| 04047844005705 | K090387 | 000 |
| 04047844005712 | K090387 | 000 |
| 04047844005729 | K090387 | 000 |
| 04047844005736 | K090387 | 000 |
| 04047844005743 | K090387 | 000 |
| 04047844005750 | K090387 | 000 |
| 04047844005996 | K090387 | 000 |
| 04047844006009 | K090387 | 000 |
| 04047844005668 | K090387 | 000 |