The following data is part of a premarket notification filed by Signus Medical with the FDA for Diana Fusion Cage.
| Device ID | K091122 |
| 510k Number | K091122 |
| Device Name: | DIANA FUSION CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SIGNUS MEDICAL 1331 H STREET NW SUITE 1200 Washington, DC 20005 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen SIGNUS MEDICAL 1331 H STREET NW SUITE 1200 Washington, DC 20005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-17 |
| Decision Date | 2009-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04047844008423 | K091122 | 000 |
| 04047844008416 | K091122 | 000 |
| 04047844008409 | K091122 | 000 |
| 04047844008393 | K091122 | 000 |