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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7406700001 | K153323 | 000 |
| M7406704120 | K153323 | 000 |
| M7406704200 | K153323 | 000 |
| M7406705030 | K153323 | 000 |
| M7406705035 | K153323 | 000 |
| M7406705040 | K153323 | 000 |
| M7406705045 | K153323 | 000 |
| M7406705050 | K153323 | 000 |
| M7406705530 | K153323 | 000 |
| M7406705535 | K153323 | 000 |
| M7406705540 | K153323 | 000 |
| M7406705545 | K153323 | 000 |
| M7406705550 | K153323 | 000 |
| M7406705555 | K153323 | 000 |
| M7406705560 | K153323 | 000 |
| M7406704110 | K153323 | 000 |
| M7406704100 | K153323 | 000 |
| M7406704090 | K153323 | 000 |
| M7406700007 | K153323 | 000 |
| M7406704025 | K153323 | 000 |
| M7406704030 | K153323 | 000 |
| M7406704035 | K153323 | 000 |
| M7406704040 | K153323 | 000 |
| M7406704045 | K153323 | 000 |
| M7406704050 | K153323 | 000 |
| M7406704055 | K153323 | 000 |
| M7406704060 | K153323 | 000 |
| M7406704065 | K153323 | 000 |
| M7406704070 | K153323 | 000 |
| M7406704075 | K153323 | 000 |
| M7406704080 | K153323 | 000 |
| M7406704085 | K153323 | 000 |
| M7406706030 | K153323 | 000 |
| M7406706035 | K153323 | 000 |
| M7406706040 | K153323 | 000 |
| M7406706555 | K153323 | 000 |
| M7406706560 | K153323 | 000 |
| M7406706565 | K153323 | 000 |
| M7406707500 | K153323 | 000 |
| M7406707530 | K153323 | 000 |
| M7406707535 | K153323 | 000 |
| M7406707540 | K153323 | 000 |
| M7406707545 | K153323 | 000 |
| M7406707550 | K153323 | 000 |
| M7406707555 | K153323 | 000 |
| M7406707560 | K153323 | 000 |
| M7406707565 | K153323 | 000 |
| M7406707570 | K153323 | 000 |
| M7406707580 | K153323 | 000 |
| M7406706550 | K153323 | 000 |
| M7406706545 | K153323 | 000 |
| M7406706540 | K153323 | 000 |
| M7406706045 | K153323 | 000 |
| M7406706050 | K153323 | 000 |
| M7406706055 | K153323 | 000 |
| M7406706060 | K153323 | 000 |
| M7406706065 | K153323 | 000 |
| M7406706070 | K153323 | 000 |
| M7406706075 | K153323 | 000 |
| M7406706080 | K153323 | 000 |
| M7406706090 | K153323 | 000 |
| M7406706100 | K153323 | 000 |
| M7406706110 | K153323 | 000 |
| M7406706120 | K153323 | 000 |
| M7406706530 | K153323 | 000 |
| M7406706535 | K153323 | 000 |
| M7406707590 | K153323 | 000 |