Endoskeleton TCS Interbody Fusion Device
FDA 510(k) K151596 · Titan Spine, LLC
510(k) numberK151596
Submission
- Device name
- Endoskeleton TCS Interbody Fusion Device
- Applicant
- Titan Spine, LLC
Mequon, WI, US - Received
- June 12, 2015
- Decision date
- October 9, 2015
- 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 |
More from Evolution Spine
| 510(k) | Device | Decision |
|---|---|---|
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…OVD · Traditional | 01/08/2020SE |
| K192054 | Endoskeleton TAS PlateOVD · Special | 08/29/2019SE |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…ODP · Special | 08/16/2019SE |
| K191565 | Endoskeleton TCS Interbody Fusion DeviceOVE · Special | 08/06/2019SE |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…ODP · Special | 02/11/2019SE |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…ODP · Special | 02/13/2018SE |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD)MAX · Traditional | 07/06/2017SE |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic…OVD · Traditional | 04/13/2017SE |
| K153122 | Endoskeleton(r) TCS SystemOVE · Traditional | 12/14/2015SE |
| K142940 | Endoskeleton TCS SystemOVE · Traditional | 01/28/2015SE |
Questions and answers
When was Endoskeleton TCS Interbody Fusion Device cleared by the FDA?
Endoskeleton TCS Interbody Fusion Device (K151596) received a 510(k) decision of Substantially Equivalent on October 9, 2015, 119 days after the submission was received.
What is the product code of K151596?
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.