NuVasive(R) CCX-L Interbody System
FDA 510(k) K143595 · Nu Vasive, Incorporated
510(k) numberK143595
Submission
- Device name
- NuVasive(R) CCX-L Interbody System
- Applicant
- Nu Vasive, Incorporated
San Diego, CA, US - Received
- December 18, 2014
- Decision date
- April 29, 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 |
| 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 |
|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…ODP · Special | 07/11/2023SE |
| K230894 | NuVasive Modulus ALIF SystemOVD · Traditional | 06/16/2023SE |
| K230989 | Rod Registration FrameOLO · Special | 05/05/2023SE |
| K223181 | NuVasive Reline SystemNKB · Traditional | 01/11/2023SE |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional | 10/21/2022SE |
| K221388 | NuVasive Reline Cervical SystemNKG · Traditional | 09/09/2022SE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional | 06/21/2022SE |
| K213654 | NuVasive Reline Cervical SystemNKG · Traditional | 02/23/2022SE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional | 12/23/2021SE |
| K212446 | NuVasive Anterior Cervical Plate SystemsKWQ · Traditional | 11/03/2021SE |
Questions and answers
When was NuVasive(R) CCX-L Interbody System cleared by the FDA?
NuVasive(R) CCX-L Interbody System (K143595) received a 510(k) decision of Substantially Equivalent on April 29, 2015, 132 days after the submission was received.
What is the product code of K143595?
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.