The following data is part of a premarket notification filed by Signus Medical Llc. with the FDA for Conklusion Pedicle Screw System.
| Device ID | K031455 |
| 510k Number | K031455 |
| Device Name: | CONKLUSION PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SIGNUS MEDICAL LLC. 6713 LAKEWAY DR. Chanhassen, MN 55317 |
| Contact | Thomas Hoghaug |
| Correspondent | Thomas Hoghaug SIGNUS MEDICAL LLC. 6713 LAKEWAY DR. Chanhassen, MN 55317 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-07 |
| Decision Date | 2003-10-22 |
| Summary: | summary |