The following data is part of a premarket notification filed by Signus Medical Llc. with the FDA for Monopoly Pedicle Screw System.
| Device ID | K081108 |
| 510k Number | K081108 |
| Device Name: | MONOPOLY PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SIGNUS MEDICAL LLC. 1331 H ST NW SUITE 1200 Washington, DC 20005 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen SIGNUS MEDICAL LLC. 1331 H ST NW SUITE 1200 Washington, DC 20005 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-18 |
| Decision Date | 2008-07-14 |
| Summary: | summary |