Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
FDA 510(k) K252240 · Spectrum Spine
510(k) numberK252240
Submission
- Device name
- Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
- Applicant
- Spectrum Spine
Jasper, GA, US - Received
- July 17, 2025
- Decision date
- March 30, 2026
- 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 |
|---|---|---|
| K253377 | Expandable Titanium PLIF/TLIF SystemMAX · Special | 10/24/2025SE |
| K243074 | Spectrum Spine Lumbar Cage SystemMAX · Traditional | 04/04/2025SE |
| K240838 | Spectrum Spine Cervical Cage SystemODP · Traditional | 05/30/2024SE |
| K201024 | Expandable Titanium PLIF/TLIF SystemMAX · Traditional | 04/29/2021SE |
| K173518 | Spectrum Spine Expandable Cages (SSEC)MAX · Traditional | 03/07/2019SE |
| K132126 | Spectrum Spine Fenestrated Facet Screw SystemMRW · Traditional | 10/28/2013SE |
| K122822 | Spectrum Spine Laminoplasty Plating SystemNQW · Traditional | 02/07/2013SE |
Questions and answers
When was Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System cleared by the FDA?
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (K252240) received a 510(k) decision of Substantially Equivalent on March 30, 2026, 256 days after the submission was received.
What is the product code of K252240?
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.