InTice™-C Porous Ti Cervical Interbody System

Intervertebral Fusion Device With Bone Graft, Cervical

X-Spine Systems, Inc.

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.

Pre-market Notification Details

Device IDK173832
510k NumberK173832
Device Name:InTice™-C Porous Ti Cervical Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant X-Spine Systems, Inc. 452 Alexandersville Rd. Miamisburg,  OH  45342
ContactCharlene Brumbaugh
CorrespondentCharlene Brumbaugh
X-Spine Systems, Inc. 452 Alexandersville Rd. Miamisburg,  OH  45342
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-18
Decision Date2018-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M697X0980408STR1 K173832 000
M697X0980605STR1 K173832 000
M697X0980606STR1 K173832 000
M697X0980607STR1 K173832 000
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M697X0980611STR1 K173832 000
M697X0980612STR1 K173832 000
M697X0980105STR1 K173832 000
M697X0980106STR1 K173832 000
M697X0980512STR1 K173832 000
M697X0980511STR1 K173832 000
M697X0980409STR1 K173832 000
M697X0980410STR1 K173832 000
M697X0980411STR1 K173832 000
M697X0980412STR1 K173832 000
M697X0980505STR1 K173832 000
M697X0980506STR1 K173832 000
M697X0980507STR1 K173832 000
M697X0980508STR1 K173832 000
M697X0980509STR1 K173832 000
M697X0980510STR1 K173832 000
M697X0980107STR1 K173832 000
M697X0980108STR1 K173832 000
M697X0980305STR1 K173832 000
M697X0980306STR1 K173832 000
M697X0980307STR1 K173832 000
M697X0980308STR1 K173832 000
M697X0980309STR1 K173832 000
M697X0980310STR1 K173832 000
M697X0980311STR1 K173832 000
M697X0980312STR1 K173832 000
M697X0980405STR1 K173832 000
M697X0980406STR1 K173832 000
M697X0980212STR1 K173832 000
M697X0980211STR1 K173832 000
M697X0980109STR1 K173832 000
M697X0980110STR1 K173832 000
M697X0980111STR1 K173832 000
M697X0980112STR1 K173832 000
M697X0980205STR1 K173832 000
M697X0980206STR1 K173832 000
M697X0980207STR1 K173832 000
M697X0980208STR1 K173832 000
M697X0980209STR1 K173832 000
M697X0980210STR1 K173832 000
M697X0980407STR1 K173832 000

Trademark Results [InTice]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTICE
INTICE
98254820 not registered Live/Pending
ROCKWELL LABS LTD
2023-11-03
INTICE
INTICE
87526733 not registered Live/Pending
X-spine Systems, Inc.
2017-07-13
INTICE
INTICE
85534720 not registered Dead/Abandoned
Cargo Management Enterprises, Inc.
2012-02-06
INTICE
INTICE
85507167 4314230 Live/Registered
Intice, Inc.
2012-01-02

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