Eminent Spine 3D Cervical Interbody Fusion System
FDA 510(k) K212701 · Eminent Spine
510(k) numberK212701
Submission
- Device name
- Eminent Spine 3D Cervical Interbody Fusion System
- Applicant
- Eminent Spine
Plano, TX, US - Received
- August 25, 2021
- Decision date
- February 6, 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 |
|---|---|---|
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | 10/07/2025SE |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw SystemNKB · Traditional | 04/28/2025SE |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKB · Special | 09/03/2024SE |
| K240505 | Eminent Spine SI Screw SystemOUR · Traditional | 06/04/2024SE |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion SystemsMAX · Traditional | 05/16/2023SE |
| K221936 | Standalone ALIF Interbody Fusion SystemOVD · Traditional | 10/17/2022SE |
| K212853 | Cervical Stand-Alone SystemOVE · Traditional | 11/05/2021SE |
| K201979 | Cervical Plate SystemKWQ · Traditional | 08/25/2020SE |
| K143365 | Eminent Foot Plate SystemHRS · Traditional | 03/30/2015SE |
| K133194 | Diamond Rattlesnake SystemKWQ · Traditional | 06/26/2014SE |
Questions and answers
When was Eminent Spine 3D Cervical Interbody Fusion System cleared by the FDA?
Eminent Spine 3D Cervical Interbody Fusion System (K212701) received a 510(k) decision of Substantially Equivalent on February 6, 2023, 530 days after the submission was received.
What is the product code of K212701?
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.