The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Intice™-c Porous Ti Cervical Interbody System.
Device ID | K173832 |
510k Number | K173832 |
Device Name: | InTice™-C Porous Ti Cervical Interbody System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | X-Spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 |
Contact | Charlene Brumbaugh |
Correspondent | Charlene Brumbaugh X-Spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-18 |
Decision Date | 2018-05-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTICE 98254820 not registered Live/Pending |
ROCKWELL LABS LTD 2023-11-03 |
INTICE 87526733 not registered Live/Pending |
X-spine Systems, Inc. 2017-07-13 |
INTICE 85534720 not registered Dead/Abandoned |
Cargo Management Enterprises, Inc. 2012-02-06 |
INTICE 85507167 4314230 Live/Registered |
Intice, Inc. 2012-01-02 |