The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Fortress Pedicle Screw System.
| Device ID | K140010 |
| 510k Number | K140010 |
| Device Name: | FORTRESS PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINEOLOGY, INC. 7800 3RD ST NORTH SUITE 600 St. Paul, MN 55128 |
| Contact | Karen Roche |
| Correspondent | Karen Roche SPINEOLOGY, INC. 7800 3RD ST NORTH 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-02 |
| Decision Date | 2014-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7406400025 | K140010 | 000 |
| M7406404525 | K140010 | 000 |
| M7406404530 | K140010 | 000 |
| M7406404535 | K140010 | 000 |
| M7406404540 | K140010 | 000 |
| M7406404545 | K140010 | 000 |
| M7406404550 | K140010 | 000 |
| M7406405000 | K140010 | 000 |
| M7406405525 | K140010 | 000 |
| M7406405530 | K140010 | 000 |
| M7406405535 | K140010 | 000 |
| M7406405540 | K140010 | 000 |
| M7406405545 | K140010 | 000 |
| M7406405550 | K140010 | 000 |
| M7406405555 | K140010 | 000 |
| M7406405560 | K140010 | 000 |
| M7406406000 | K140010 | 000 |
| M7406406525 | K140010 | 000 |
| M7406401017 | K140010 | 000 |
| M7406401005 | K140010 | 000 |
| M7406400030 | K140010 | 000 |
| M7406400035 | K140010 | 000 |
| M7406400040 | K140010 | 000 |
| M7406400045 | K140010 | 000 |
| M7406400050 | K140010 | 000 |
| M7406400055 | K140010 | 000 |
| M7406400060 | K140010 | 000 |
| M7406400065 | K140010 | 000 |
| M7406400070 | K140010 | 000 |
| M7406400075 | K140010 | 000 |
| M7406400080 | K140010 | 000 |
| M7406400085 | K140010 | 000 |
| M7406400090 | K140010 | 000 |
| M7406400100 | K140010 | 000 |
| M7406400110 | K140010 | 000 |
| M7406400120 | K140010 | 000 |
| M7406400200 | K140010 | 000 |
| M7406406530 | K140010 | 000 |
| M7406406535 | K140010 | 000 |
| M7406407545 | K140010 | 000 |
| M7406407550 | K140010 | 000 |
| M7406407555 | K140010 | 000 |
| M7406407560 | K140010 | 000 |
| M7406407565 | K140010 | 000 |
| M7406408525 | K140010 | 000 |
| M7406408530 | K140010 | 000 |
| M7406408535 | K140010 | 000 |
| M7406408540 | K140010 | 000 |
| M7406408545 | K140010 | 000 |
| M7406408550 | K140010 | 000 |
| M7406408555 | K140010 | 000 |
| M7406408560 | K140010 | 000 |
| M7406408565 | K140010 | 000 |
| M7406408570 | K140010 | 000 |
| M7406408580 | K140010 | 000 |
| M7406408590 | K140010 | 000 |
| M7406407540 | K140010 | 000 |
| M7406407535 | K140010 | 000 |
| M7406406540 | K140010 | 000 |
| M7406406545 | K140010 | 000 |
| M7406406550 | K140010 | 000 |
| M7406406555 | K140010 | 000 |
| M7406406560 | K140010 | 000 |
| M7406406565 | K140010 | 000 |
| M7406407025 | K140010 | 000 |
| M7406407030 | K140010 | 000 |
| M7406407035 | K140010 | 000 |
| M7406407040 | K140010 | 000 |
| M7406407045 | K140010 | 000 |
| M7406407050 | K140010 | 000 |
| M7406407055 | K140010 | 000 |
| M7406407060 | K140010 | 000 |
| M7406407065 | K140010 | 000 |
| M7406407525 | K140010 | 000 |
| M7406407530 | K140010 | 000 |
| M7406408599 | K140010 | 000 |