The following data is part of a premarket notification filed by Evolution Spine with the FDA for Emerge™ Anterior Cervical Plate System.
Device ID | K212405 |
510k Number | K212405 |
Device Name: | EMERGE™ Anterior Cervical Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Evolution Spine 2300 N. Haskell Ave Dallas, TX 75204 |
Contact | Todd Wallenstein |
Correspondent | Todd Wallenstein Evolution Spine 2300 N. Haskell Ave Dallas, TX 75204 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-02 |
Decision Date | 2021-09-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EMERGE 98556235 not registered Live/Pending |
Andis Company 2024-05-17 |
EMERGE 98527047 not registered Live/Pending |
EMERGE 2024-04-30 |
EMERGE 98238168 not registered Live/Pending |
Palmetto State Armory, LLC 2023-10-24 |
EMERGE 98226422 not registered Live/Pending |
EMERGE LABS LLC 2023-10-16 |
EMERGE 98190290 not registered Live/Pending |
Nvision Biomedical Technologies, Inc. 2023-09-21 |
EMERGE 98187243 not registered Live/Pending |
WorkLife Brands LLC 2023-09-19 |
EMERGE 98115954 not registered Live/Pending |
A. O. Smith Corporation 2023-08-03 |
EMERGE 98043982 not registered Live/Pending |
The City Bible Center Church of Charleston 2023-06-15 |
EMERGE 97915397 not registered Live/Pending |
Andis Company 2023-05-01 |
EMERGE 97704028 not registered Live/Pending |
Hollywood Bed and Spring Manufacturing Co., Inc. 2022-12-05 |
EMERGE 97301976 not registered Live/Pending |
Edec Digital Forensics, LLC 2022-03-08 |
EMERGE 97270591 not registered Live/Pending |
Emerge Capital Management Inc. 2022-02-16 |