Solitaire-C Cervical Spacer System
FDA 510(k) K113796 · Ebi, LLC
510(k) numberK113796
Submission
- Device name
- Solitaire-C Cervical Spacer System
- Applicant
- Ebi, LLC
Parsippany, NJ, US - Received
- December 23, 2011
- Decision date
- April 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.
Other 510(k)s with product code OVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | Nexus Spine | 06/22/2026SE |
| K252982 | CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional | Avalign Technologies, Inc. | 06/18/2026SE |
| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
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| K190837 | Internal Hex Implant SystemDZE · Traditional | 01/22/2020SE |
| K170031 | Internal Octa Implant SystemDZE · Traditional | 08/31/2017SE |
| K142426 | EBI External Implant SystemDZE · Traditional | 03/27/2015SE |
| K140734 | Nextgen Altius Oct SystemKWP · Traditional | 12/15/2014SE |
| K140123 | Polaris Spinal System -Translation ScrewNKB · Traditional | 04/24/2014SE |
| K111376 | Construx External Fixation DeviceKTT · Traditional | 08/03/2011SE |
| K073116 | Ebi Internal Implant SystemDZE · Traditional | 02/28/2008SE |
Questions and answers
When was Solitaire-C Cervical Spacer System cleared by the FDA?
Solitaire-C Cervical Spacer System (K113796) received a 510(k) decision of Substantially Equivalent on April 26, 2012, 125 days after the submission was received.
What is the product code of K113796?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.