Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System
Thoracolumbosacral Pedicle Screw System
Spineology Inc.
The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System.
Pre-market Notification Details
| Device ID | K172107 |
| 510k Number | K172107 |
| Device Name: | Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spineology Inc. 7800 3rd Street North St. Paul, MN 55128 |
| Contact | Jacqueline A. Hauge |
| Correspondent | Jacqueline A. Hauge Spineology Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-12 |
| Decision Date | 2017-08-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7406704095 | K172107 | 000 |
| M7405514550 | K172107 | 000 |
| M7405514545 | K172107 | 000 |
| M7405514540 | K172107 | 000 |
| M7405514535 | K172107 | 000 |
| M7405514530 | K172107 | 000 |
| M7405514525 | K172107 | 000 |
| M7405507599 | K172107 | 000 |
| M7405507590 | K172107 | 000 |
| M7405507580 | K172107 | 000 |
| M7405507570 | K172107 | 000 |
| M7405504550 | K172107 | 000 |
| M7405504545 | K172107 | 000 |
| M7405504540 | K172107 | 000 |
| M7405504535 | K172107 | 000 |
| M7405504530 | K172107 | 000 |
| M7405504525 | K172107 | 000 |
| M7405517570 | K172107 | 000 |
| M7405517580 | K172107 | 000 |
| M7405717599 | K172107 | 000 |
| M7405717590 | K172107 | 000 |
| M7405717580 | K172107 | 000 |
| M7405717570 | K172107 | 000 |
| M7405707599 | K172107 | 000 |
| M7405707590 | K172107 | 000 |
| M7405707580 | K172107 | 000 |
| M7405707570 | K172107 | 000 |
| M7405704550 | K172107 | 000 |
| M7405704545 | K172107 | 000 |
| M7405704540 | K172107 | 000 |
| M7405704535 | K172107 | 000 |
| M7405704530 | K172107 | 000 |
| M7405704525 | K172107 | 000 |
| M7405517599 | K172107 | 000 |
| M7405517590 | K172107 | 000 |
| M7405501500 | K172107 | 000 |
Trademark Results [Threshold]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THRESHOLD 98468506 not registered Live/Pending |
Threshold Care, Inc. 2024-03-26 |
 THRESHOLD 97906376 not registered Live/Pending |
Threshold Rising, LLC 2023-04-25 |
 THRESHOLD 97906365 not registered Live/Pending |
Threshold Rising, LLC 2023-04-25 |
 THRESHOLD 97510531 not registered Live/Pending |
Kingspan Insulation LLC 2022-07-19 |
 THRESHOLD 97396217 not registered Live/Pending |
Pa, GuangFu 2022-05-05 |
 THRESHOLD 97369674 not registered Live/Pending |
Auricle Productions 2022-04-19 |
 THRESHOLD 88857853 not registered Live/Pending |
Vino Vida Wines, LLC 2020-04-02 |
 THRESHOLD 88701943 not registered Live/Pending |
TONINA MUSIC INC. 2019-11-21 |
 THRESHOLD 88317809 5942027 Live/Registered |
Data Management, Incorporated 2019-02-27 |
 THRESHOLD 88099965 not registered Live/Pending |
Threshold Shows, PBC 2018-08-30 |
 THRESHOLD 88059091 not registered Live/Pending |
Greatbatch Ltd. 2018-07-31 |
 THRESHOLD 87490843 not registered Dead/Abandoned |
Modne, Inc. 2017-06-15 |
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