Captiva Spine FuselOX Cervical IBF System
FDA 510(k) K142586 · Captiva Spine
510(k) numberK142586
Submission
- Device name
- Captiva Spine FuselOX Cervical IBF System
- Applicant
- Captiva Spine
Jupiter, FL, US - Received
- September 15, 2014
- Decision date
- May 28, 2015
- 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 |
|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw SystemNKB · Special | 01/31/2020SE |
| K181229 | TirboLOX-C Cervical IBFDODP · Traditional | 09/19/2018SE |
| K180990 | TirboLOX-L Lumbar IBFDMAX · Traditional | 08/13/2018SE |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw SystemNKB · Traditional | 03/19/2018SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 03/02/2016SE |
| K151116 | CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 06/26/2015SE |
| K141332 | Captiva Spine SmartLOX Cervical Plate SystemKWQ · Traditional | 06/11/2015SE |
| K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemMNH · Special | 08/08/2013SE |
| K122956 | Fuselox Lumbar Interbody Fusion DeviceMAX · Special | 10/25/2012SE |
| K122332 | Towerlox Pedicle Screw SystemMNI · Special | 10/16/2012SE |
Questions and answers
When was Captiva Spine FuselOX Cervical IBF System cleared by the FDA?
Captiva Spine FuselOX Cervical IBF System (K142586) received a 510(k) decision of Substantially Equivalent on May 28, 2015, 255 days after the submission was received.
What is the product code of K142586?
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.