Avenue T TLIF Cage
FDA 510(k) K142645 · Ldr Spine USA, Inc.
510(k) numberK142645
Submission
- Device name
- Avenue T TLIF Cage
- Applicant
- Ldr Spine USA, Inc.
Austin, TX, US - Received
- September 17, 2014
- Decision date
- June 11, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar 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 OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K162133 | VerteFIT Corpectomy Cage SystemMQP · Traditional | 05/16/2017SE |
| K161173 | Avenue® T TLIF CageOVD · Traditional | 09/28/2016SE |
| K161798 | FacetBRIDGE® SystemMRW · Special | 08/04/2016SE |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…MAX · Traditional | 03/31/2016SE |
| K152137 | FacetBRIDGE SystemMRW · Traditional | 01/25/2016SE |
| K151934 | ROI-C Titanium-Coated Implant SystemOVE · Traditional | 12/07/2015SE |
| K150765 | LDR Spine ROI-C Cervical Cage SystemOVE · Traditional | 09/17/2015SE |
| K133363 | Interbridge Interspinous Posterior Fixation SystemPEK · Traditional | 03/07/2014SE |
| K123134 | Easyspine SystemNKB · Traditional | 02/01/2013SE |
| K121103 | LDR Spine USA Spine Tune, TL Spinal System, LDR Spine USA Easyspine, Posterior Spinal…NKB · Traditional | 08/24/2012SE |
Questions and answers
When was Avenue T TLIF Cage cleared by the FDA?
Avenue T TLIF Cage (K142645) received a 510(k) decision of Substantially Equivalent on June 11, 2015, 267 days after the submission was received.
What is the product code of K142645?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.