The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Threshold™ Pedicular Fixation System.
Device ID | K161694 |
510k Number | K161694 |
Device Name: | Threshold™ Pedicular Fixation System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Spineology Inc. 7800 3rd Street N, Suite 600 St. Paul, MN 55128 -5455 |
Contact | Jacqueline A. Hauge |
Correspondent | Jacqueline A. Hauge Spineology Inc. 7800 3rd Street N, Suite 600 St. 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-20 |
Decision Date | 2016-07-15 |
Summary: | summary |
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 |