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 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M697X0980408STR1	K173832	000
M697X0980605STR1	K173832	000
M697X0980606STR1	K173832	000
M697X0980607STR1	K173832	000
M697X0980608STR1	K173832	000
M697X0980609STR1	K173832	000
M697X0980610STR1	K173832	000
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