The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Palisade Pedicular Fixation System.
| Device ID | K153323 |
| 510k Number | K153323 |
| Device Name: | Palisade Pedicular Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINEOLOGY, INC. 7800 3RD STREET NORTH Saint Paul, MN 55128 -5455 |
| Contact | Jacqueline A Hauge |
| Correspondent | Jacqueline A Hauge SPINEOLOGY, INC. 7800 3RD STREET NORTH Saint Paul, MN 55128 -5455 |
| Product Code | NKB |
| 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 | 2015-11-18 |
| Decision Date | 2016-02-23 |
| Summary: | summary |