InTice-C Porous Ti Cervical Interbody System
FDA 510(k) K173832 · X-Spine Systems, Inc.
510(k) numberK173832
Submission
- Device name
- InTice-C Porous Ti Cervical Interbody System
- Applicant
- X-Spine Systems, Inc.
Miamisburg, OH, US - Received
- December 18, 2017
- Decision date
- May 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K180153 | X-spine Cortical Bone Screw SystemNKB · Traditional | 03/15/2018SE |
| K170119 | Calix Lumbar Spinal Implant SystemMAX · Traditional | 09/29/2017SE |
| K171567 | IRIX-A Lumbar Integrated Fusion SystemOVD · Traditional | 08/28/2017SE |
| K171075 | Calix-C Cervical Interbody SpacerODP · Traditional | 08/01/2017SE |
| K170224 | Spider Cervical Plating SystemKWQ · Traditional | 07/06/2017SE |
| K170530 | Butrex Lumbar Buttress Plating SystemKWQ · Special | 03/22/2017SE |
| K160959 | Xsert Lumbar Expandable Interbody SystemMAX · Traditional | 11/17/2016SE |
| K162944 | Irix-C Cervical Integrated Fusion SystemOVE · Traditional | 11/07/2016SE |
| K160428 | Certex Spinal Fixation SystemNKG · Traditional | 05/05/2016SE |
| K160114 | Xspan Laminoplasty Fixation SystemNQW · Traditional | 03/15/2016SE |
Questions and answers
When was InTice-C Porous Ti Cervical Interbody System cleared by the FDA?
InTice-C Porous Ti Cervical Interbody System (K173832) received a 510(k) decision of Substantially Equivalent on May 17, 2018, 150 days after the submission was received.
What is the product code of K173832?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.