The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Infinity™ Oct System.
Device ID | K163375 |
510k Number | K163375 |
Device Name: | INFINITY™ OCT System |
Classification | Posterior Cervical Screw System |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
Contact | Tejas Patel |
Correspondent | Tejas Patel Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-01 |
Decision Date | 2017-08-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INFINITY 98454204 not registered Live/Pending |
Tanks By Mail Inc 2024-03-18 |
INFINITY 98433629 not registered Live/Pending |
Infinity Generation Inc. 2024-03-05 |
INFINITY 98338571 not registered Live/Pending |
Careismatic Brands, LLC 2024-01-02 |
INFINITY 98293120 not registered Live/Pending |
PREFERRED COLLECTIONS INC. 2023-11-30 |
INFINITY 98275942 not registered Live/Pending |
Capital One Financial Corporation 2023-11-17 |
INFINITY 98242984 not registered Live/Pending |
IGH Holding Inc. 2023-10-27 |
INFINITY 98175956 not registered Live/Pending |
CellFE, Inc. 2023-09-12 |
INFINITY 98171540 not registered Live/Pending |
AccuTec, Inc. 2023-09-08 |
INFINITY 98058654 not registered Live/Pending |
Encore RV LLC 2023-06-26 |
INFINITY 98049650 not registered Live/Pending |
Induplate Operations, LLC 2023-06-19 |
INFINITY 98032206 not registered Live/Pending |
Hope Medical 2023-06-07 |
INFINITY 98027840 not registered Live/Pending |
Careismatic Brands, LLC 2023-06-05 |