ORIO-Ti Intervertebral Body Fusion Cage System
FDA 510(k) K211935 · Spinecraft, LLC
510(k) numberK211935
Submission
- Device name
- ORIO-Ti Intervertebral Body Fusion Cage System
- Applicant
- Spinecraft, LLC
Westmont, IL, US - Received
- June 22, 2021
- Decision date
- September 30, 2021
- 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 |
|---|---|---|
| K253260 | ORIO-3D Cage SystemODP · Traditional | 04/16/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | 03/04/2026SE |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemOLO · Traditional | 07/20/2023SE |
| K223273 | ASTRA Spine SystemNKB · Traditional | 12/22/2022SE |
| K211323 | ASTRA Spine SystemNKB · Special | 06/03/2021SE |
| K181350 | ASTRA-OCT Spine SystemNKG · Traditional | 07/06/2018SE |
| K143683 | APEX-DL Spine SystemNKB · Traditional | 05/22/2015SE |
| K150417 | Astra Spine SystemNKB · Traditional | 05/19/2015SE |
| K131521 | Velox Anterior Cervical Plate SystemKWQ · Traditional | 12/24/2013SE |
| K132603 | Apex Spine SystemNKB · Traditional | 11/20/2013SE |
Questions and answers
When was ORIO-Ti Intervertebral Body Fusion Cage System cleared by the FDA?
ORIO-Ti Intervertebral Body Fusion Cage System (K211935) received a 510(k) decision of Substantially Equivalent on September 30, 2021, 100 days after the submission was received.
What is the product code of K211935?
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.