The following data is part of a premarket notification filed by Signus Medical Llc. with the FDA for Peek Tetris Spinal Implant.
| Device ID | K031757 |
| 510k Number | K031757 |
| Device Name: | PEEK TETRIS SPINAL IMPLANT |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SIGNUS MEDICAL LLC. 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Contact | Al Alexander |
| Correspondent | Al Alexander SIGNUS MEDICAL LLC. 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-06 |
| Decision Date | 2003-07-30 |
| Summary: | summary |