The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Threshold Pedicular Fixation System.
| Device ID | K143403 |
| 510k Number | K143403 |
| Device Name: | Threshold Pedicular Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spineology, Inc. 7800 3rd Street N. Saint Paul, MN 55128 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree Spineology, Inc. 7800 3rd Street N. Saint 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 | 2014-11-28 |
| Decision Date | 2014-12-18 |
| Summary: | summary |