The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Tetris Ii.
| Device ID | K122317 |
| 510k Number | K122317 |
| Device Name: | TETRIS II |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH PO BOX 566 Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden SIGNUS MEDIZINTECHNIK GMBH PO BOX 566 Chesterland, OH 44026 -2141 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-08-29 |
| Summary: | summary |