Arena-C Tifuse Cervical Intervertebral Body Fusion Device
FDA 510(k) K141333 · Spinefrontier, Inc.
510(k) numberK141333
Submission
- Device name
- Arena-C Tifuse Cervical Intervertebral Body Fusion Device
- Applicant
- Spinefrontier, Inc.
Colorado Springs, CO, US - Received
- May 21, 2014
- Decision date
- November 25, 2014
- 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 |
|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Special | 06/19/2020SE |
| K172484 | A-CIFT SoloFuseOVE · Traditional | 05/08/2018SE |
| K151198 | A-CIFT SoloFuseOVE · Special | 07/17/2015SE |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Traditional | 05/13/2015SE |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemOUR · Traditional | 04/24/2015SE |
| K143377 | PedFuse Pedicle Screw SystemMNH · Special | 02/12/2015SE |
| K142026 | Spinefrontier Arena-C Ha PEEK Cervical Intervertebral Body Fusion DeviceODP · Traditional | 10/20/2014SE |
| K141337 | Arena-CODP · Traditional | 09/08/2014SE |
| K133153 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Special | 05/14/2014SE |
| K131880 | Spinefrontier A-Cift Solofuse Cervical Intervertebral Fusion Device SystemOVE · Abbreviated | 01/03/2014SE |
Questions and answers
When was Arena-C Tifuse Cervical Intervertebral Body Fusion Device cleared by the FDA?
Arena-C Tifuse Cervical Intervertebral Body Fusion Device (K141333) received a 510(k) decision of Substantially Equivalent on November 25, 2014, 188 days after the submission was received.
What is the product code of K141333?
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.