Curiteva Porous PEEK Cervical Interbody Fusion System
FDA 510(k) K254061 · Curiteva, Inc.
510(k) numberK254061
Submission
- Device name
- Curiteva Porous PEEK Cervical Interbody Fusion System
- Applicant
- Curiteva, Inc.
Tanner, AL, US - Received
- December 17, 2025
- Decision date
- January 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…ODP · Traditional | 01/16/2026SE |
| K250845 | Curiteva Porous PEEK Standalone ALIF SystemOVD · Traditional | 06/18/2025SE |
| K243137 | Curiteva Porous PEEK Laminoplasty SystemNQW · Special | 10/28/2024SE |
| K233360 | Curiteva Thoracolumbar Plate SystemKWQ · Traditional | 02/29/2024SE |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion SystemMAX · Traditional | 01/18/2024SE |
| K231232 | Curiteva Laminoplasty SystemNQW · Traditional | 06/28/2023SE |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion SystemODP · Traditional | 02/13/2023SE |
| K223200 | Curiteva Navigation SystemOLO · Traditional | 01/06/2023SE |
| K210402 | Curiteva Sacroiliac Joint Fusion SystemOUR · Traditional | 09/09/2021SE |
| K191810 | Curiteva Pedicle Screw SystemNKB · Traditional | 08/28/2019SE |
Questions and answers
When was Curiteva Porous PEEK Cervical Interbody Fusion System cleared by the FDA?
Curiteva Porous PEEK Cervical Interbody Fusion System (K254061) received a 510(k) decision of Substantially Equivalent on January 15, 2026, 29 days after the submission was received.
What is the product code of K254061?
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.