The following data is part of a premarket notification filed by Signus Medical with the FDA for Monopoly Pedicle Screw System.
| Device ID | K092073 |
| 510k Number | K092073 |
| Device Name: | MONOPOLY PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SIGNUS MEDICAL 188888 LAKE DRIVE EAST Chanhassen, MN 55317 |
| Contact | Thomas Hoghaug |
| Correspondent | Thomas Hoghaug SIGNUS MEDICAL 188888 LAKE DRIVE EAST Chanhassen, MN 55317 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-08 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04047844006306 | K092073 | 000 |
| 04047844006146 | K092073 | 000 |
| 04047844006139 | K092073 | 000 |
| 04047844006122 | K092073 | 000 |
| 04047844006115 | K092073 | 000 |
| 04047844006108 | K092073 | 000 |
| 04047844006092 | K092073 | 000 |
| 04047844006085 | K092073 | 000 |
| 04047844006078 | K092073 | 000 |
| 04047844006061 | K092073 | 000 |
| 04047844006054 | K092073 | 000 |
| 04047844006047 | K092073 | 000 |
| 04047844006030 | K092073 | 000 |
| 04047844006023 | K092073 | 000 |
| 04047844006153 | K092073 | 000 |
| 04047844006160 | K092073 | 000 |
| 04047844006290 | K092073 | 000 |
| 04047844006283 | K092073 | 000 |
| 04047844006276 | K092073 | 000 |
| 04047844006269 | K092073 | 000 |
| 04047844006252 | K092073 | 000 |
| 04047844006245 | K092073 | 000 |
| 04047844006238 | K092073 | 000 |
| 04047844006221 | K092073 | 000 |
| 04047844006214 | K092073 | 000 |
| 04047844006207 | K092073 | 000 |
| 04047844006191 | K092073 | 000 |
| 04047844006184 | K092073 | 000 |
| 04047844006177 | K092073 | 000 |
| 04047844006016 | K092073 | 000 |