Valeo Spacer System and Valeo II Interbody Fusion Device System
FDA 510(k) K143518 · Amedica Corp.
510(k) numberK143518
Submission
- Device name
- Valeo Spacer System and Valeo II Interbody Fusion Device System
- Applicant
- Amedica Corp.
Slat Lake City, UT, US - Received
- December 12, 2014
- Decision date
- October 2, 2015
- 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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| 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 |
|---|---|---|
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion DeviceODP · Traditional | 03/05/2018SE |
| K162160 | Preference Elite Pedicle Screw SystemNKB · Traditional | 11/18/2016SE |
| K161405 | Valeo II Interbody Fusion Device SystemMAX · Special | 08/19/2016SE |
| K142264 | Valeo C Spacer System, Valeo II C IBF DeviceODP · Traditional | 12/08/2014SE |
| K142347 | Amedica Valeo II Interbody Fusion DeviceMAX · Traditional | 11/18/2014SE |
| K121892 | Phantom Plus Ceramic Cage SystemMAX · Special | 08/24/2012SE |
| K091278 | Valeo Spacer SystemMAX · Traditional | 01/28/2010SE |
| K082037 | Seeplate Cervical Plate SystemKWQ · Special | 09/26/2008SE |
| K073430 | Valeo Pedicle Screw Spinal SystemNKB · Traditional | 01/29/2008SE |
| K073505 | Modification to Valeo VBRMQP · Special | 01/09/2008SE |
Questions and answers
When was Valeo Spacer System and Valeo II Interbody Fusion Device System cleared by the FDA?
Valeo Spacer System and Valeo II Interbody Fusion Device System (K143518) received a 510(k) decision of Substantially Equivalent on October 2, 2015, 294 days after the submission was received.
What is the product code of K143518?
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.