The following data is part of a premarket notification filed by In2bones Sas with the FDA for Quantum® Total Ankle Prosthesis.
Device ID | K191380 |
510k Number | K191380 |
Device Name: | Quantum® Total Ankle Prosthesis |
Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
Applicant | In2Bones SAS Ecully, FR 69130 |
Contact | Morgane Grenier |
Correspondent | Christine Scifert In2Bones USA 6000 Poplar Avenue, Suite 115 Memphis, TN 38119 |
Product Code | HSN |
CFR Regulation Number | 888.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-23 |
Decision Date | 2020-01-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUANTUM 98424129 not registered Live/Pending |
HOUSE X AMERICA LLC 2024-02-27 |
QUANTUM 98417725 not registered Live/Pending |
Meta Materials Inc. 2024-02-23 |
QUANTUM 98388177 not registered Live/Pending |
Thomas P. Dakich 2024-02-02 |
QUANTUM 98386723 not registered Live/Pending |
Kuku, Jalil 2024-02-01 |
QUANTUM 98384415 not registered Live/Pending |
Starkey Laboratories, Inc. 2024-01-31 |
QUANTUM 98362353 not registered Live/Pending |
The Upper Deck Company 2024-01-17 |
QUANTUM 98276061 not registered Live/Pending |
Jayakumar, Philip 2023-11-17 |
QUANTUM 98268023 not registered Live/Pending |
CREATIVE SYSTEMS AND DESIGN, LLC 2023-11-13 |
QUANTUM 98264792 not registered Live/Pending |
PPG INDUSTRIES OHIO, INC. 2023-11-10 |
QUANTUM 98251741 not registered Live/Pending |
SOILSON, JEFFREY A. 2023-11-02 |
QUANTUM 98239151 not registered Live/Pending |
GEA Farm Technologies, Inc. 2023-10-25 |
QUANTUM 98238680 not registered Live/Pending |
Cozzia USA, LLC 2023-10-24 |