Intervertebral Body Fusion Device
FDA 510(k) K122872 · Dio Medical Co., Ltd.
510(k) numberK122872
Submission
- Device name
- Intervertebral Body Fusion Device
- Applicant
- Dio Medical Co., Ltd.
Brea, CA, US - Received
- September 19, 2012
- Decision date
- February 28, 2013
- 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 |
|---|---|---|
| K223790 | Huvex Interspinous Fusion SystemPEK · Traditional | 03/09/2023SE |
| K223140 | AEON-C Stand Alone SystemOVE · Traditional | 12/20/2022SE |
| K222415 | Rexious Spinal Fixation SystemNKB · Traditional | 10/25/2022SE |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…KWQ · Traditional | 10/18/2022SE |
| K222448 | UNITY Sacroiliac Joint Fixation SystemOUR · Traditional | 10/13/2022SE |
| K222515 | FaSet Fixation SystemMRW · Traditional | 10/05/2022SE |
| K162849 | Huvex Interspinous Fixation SystemPEK · Traditional | 02/16/2017SE |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageODP · Traditional | 11/21/2016SE |
| K121862 | Rex Anterior Cervical Plate SystemKWQ · Traditional | 10/31/2012SE |
| K113324 | Rexious Hook Fixation SystemsKWP · Traditional | 03/28/2012SE |
Questions and answers
When was Intervertebral Body Fusion Device cleared by the FDA?
Intervertebral Body Fusion Device (K122872) received a 510(k) decision of Substantially Equivalent on February 28, 2013, 162 days after the submission was received.
What is the product code of K122872?
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.