The following data is part of a premarket notification filed by Spineology Inc with the FDA for Threshold Pedicular Fixation System, Palisade Pedicular Fixation System.
| Device ID | K160980 |
| 510k Number | K160980 |
| Device Name: | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINEOLOGY INC 7800 3RD STREET N, SUITE 600 St. Paul, MN 55128 |
| Contact | Jacqueline A Hauge |
| Correspondent | Jacqueline A Hauge SPINEOLOGY INC 7800 3RD STREET N, SUITE 600 St. Paul, MN 55128 |
| Product Code | NKB |
| 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 | 2016-04-07 |
| Decision Date | 2016-05-26 |
| Summary: | summary |