Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
FDA 510(k) K153495 · Ldr Spine USA
510(k) numberK153495
Submission
- Device name
- Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
- Applicant
- Ldr Spine USA
Austin, TX, US - Received
- December 7, 2015
- Decision date
- March 31, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
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| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 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 |
| 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 |
| K142645 | Avenue T TLIF CageOVD · Traditional | 06/11/2015SE |
| 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 L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System cleared by the FDA?
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (K153495) received a 510(k) decision of Substantially Equivalent on March 31, 2016, 115 days after the submission was received.
What is the product code of K153495?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.