Ventana C Spinal System
FDA 510(k) K222833 · Spinal Elements, Inc.
510(k) numberK222833
Submission
- Device name
- Ventana C Spinal System
- Applicant
- Spinal Elements, Inc.
Carlsbad, CA, US - Received
- September 20, 2022
- Decision date
- May 19, 2023
- 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 |
|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | 05/15/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | 02/25/2026SE |
| K250773 | Luna® Ti Interbody Fusion SystemMAX · Traditional | 02/04/2026SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | 05/21/2025SE |
| K243916 | Primus Spinal Fixation SystemNKB · Traditional | 02/21/2025SE |
| K234150 | Lucent® XPMAX · Traditional | 03/27/2024SE |
| K231593 | Sapphire X3 Anterior Cervical Plate SystemKWQ · Traditional | 08/02/2023SE |
| K231252 | Ventana L Spinal SystemMAX · Traditional | 06/30/2023SE |
| K222516 | Mercury® II Spinal SystemNKB · Traditional | 12/01/2022SE |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…MAX · Traditional | 06/30/2021SE |
Questions and answers
When was Ventana C Spinal System cleared by the FDA?
Ventana C Spinal System (K222833) received a 510(k) decision of Substantially Equivalent on May 19, 2023, 241 days after the submission was received.
What is the product code of K222833?
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.