Alamo T
FDA 510(k) K140303 · Alliance Partners, LLC
510(k) numberK140303
Submission
- Device name
- Alamo T
- Applicant
- Alliance Partners, LLC
Memphis, TN, US - Received
- February 6, 2014
- Decision date
- April 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| 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 |
|---|---|---|
| K201521 | Medina Anterior Cervical Plate SystemKWQ · Traditional | 08/06/2020SE |
| K173128 | Alamo® CODP · Traditional | 03/22/2018SE |
| K141123 | Alliance Spine Raas Cranial Plating SystemGWO · Traditional | 02/27/2015SE |
| K141993 | Nakoma AcpKWQ · Traditional | 11/06/2014SE |
| K133321 | Alamo CODP · Special | 01/09/2014SE |
| K120401 | Alamo TMAX · Traditional | 10/05/2012SE |
| K122047 | Alamo PMAX · Traditional | 09/04/2012SE |
| K121181 | Swannshidi Bone Marrow Aspiration NeedleKNW · Traditional | 08/22/2012SE |
| K112361 | Alamo CODP · Traditional | 11/30/2011SE |
Questions and answers
When was Alamo T cleared by the FDA?
Alamo T (K140303) received a 510(k) decision of Substantially Equivalent on April 21, 2014, 74 days after the submission was received.
What is the product code of K140303?
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.