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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7405305545 | K143403 | 000 |
| M7405304120 | K143403 | 000 |
| M7405304110 | K143403 | 000 |
| M7405304100 | K143403 | 000 |
| M7405304095 | K143403 | 000 |
| M7405304090 | K143403 | 000 |
| M7405304085 | K143403 | 000 |
| M7405304080 | K143403 | 000 |
| M7405304075 | K143403 | 000 |
| M7405304070 | K143403 | 000 |
| M7405304140 | K143403 | 000 |
| M7405304160 | K143403 | 000 |
| M7405304180 | K143403 | 000 |
| M7405305540 | K143403 | 000 |
| M7405305535 | K143403 | 000 |
| M7405305530 | K143403 | 000 |
| M7405305050 | K143403 | 000 |
| M7405305045 | K143403 | 000 |
| M7405305040 | K143403 | 000 |
| M7405305035 | K143403 | 000 |
| M7405305030 | K143403 | 000 |
| M7405304200 | K143403 | 000 |
| M7405304065 | K143403 | 000 |
| M7405304060 | K143403 | 000 |
| M7405304055 | K143403 | 000 |
| M7405302065 | K143403 | 000 |
| M7405302060 | K143403 | 000 |
| M7405302055 | K143403 | 000 |
| M7405302050 | K143403 | 000 |
| M7405302045 | K143403 | 000 |
| M7405302040 | K143403 | 000 |
| M7405302035 | K143403 | 000 |
| M7405302030 | K143403 | 000 |
| M7405300007 | K143403 | 000 |
| M7405302070 | K143403 | 000 |
| M7405302075 | K143403 | 000 |
| M7405302080 | K143403 | 000 |
| M7405304050 | K143403 | 000 |
| M7405304045 | K143403 | 000 |
| M7405304040 | K143403 | 000 |
| M7405304035 | K143403 | 000 |
| M7405304030 | K143403 | 000 |
| M7405302120 | K143403 | 000 |
| M7405302110 | K143403 | 000 |
| M7405302100 | K143403 | 000 |
| M7405302090 | K143403 | 000 |
| M7405300001 | K143403 | 000 |
| M7405305550 | K143403 | 000 |
| M7406307530 | K143403 | 000 |
| M7405308510 | K143403 | 000 |
| M7405307565 | K143403 | 000 |
| M7405307560 | K143403 | 000 |
| M7405307555 | K143403 | 000 |
| M7405307550 | K143403 | 000 |
| M7405307545 | K143403 | 000 |
| M7405307540 | K143403 | 000 |
| M7405307535 | K143403 | 000 |
| M7405306565 | K143403 | 000 |
| M7405308530 | K143403 | 000 |
| M7405308535 | K143403 | 000 |
| M7405308540 | K143403 | 000 |
| M7406306555 | K143403 | 000 |
| M7405308590 | K143403 | 000 |
| M7405308580 | K143403 | 000 |
| M7405308570 | K143403 | 000 |
| M7405308565 | K143403 | 000 |
| M7405308560 | K143403 | 000 |
| M7405308555 | K143403 | 000 |
| M7405308550 | K143403 | 000 |
| M7405308545 | K143403 | 000 |
| M7405306560 | K143403 | 000 |
| M7405306550 | K143403 | 000 |
| M7405306545 | K143403 | 000 |
| M7405306065 | K143403 | 000 |
| M7405306060 | K143403 | 000 |
| M7405306055 | K143403 | 000 |
| M7405306050 | K143403 | 000 |
| M7405306045 | K143403 | 000 |
| M7405306040 | K143403 | 000 |
| M7405306035 | K143403 | 000 |
| M7405306030 | K143403 | 000 |
| M7405305560 | K143403 | 000 |
| M7405306070 | K143403 | 000 |
| M7405306075 | K143403 | 000 |
| M7405306080 | K143403 | 000 |
| M7405306540 | K143403 | 000 |
| M7405306535 | K143403 | 000 |
| M7405306530 | K143403 | 000 |
| M7405306120 | K143403 | 000 |
| M7405306110 | K143403 | 000 |
| M7405306100 | K143403 | 000 |
| M7405306095 | K143403 | 000 |
| M7405306090 | K143403 | 000 |
| M7405306085 | K143403 | 000 |
| M7405305555 | K143403 | 000 |