EVOL ha - D Lateral Interbody Fusion System
FDA 510(k) K192497 · Cutting Edge Spine, LLC
510(k) numberK192497
Submission
- Device name
- EVOL ha - D Lateral Interbody Fusion System
- Applicant
- Cutting Edge Spine, LLC
Waxhaw, NC, US - Received
- September 11, 2019
- Decision date
- January 6, 2020
- 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 |
|---|---|---|
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion SystemODP · Special | 03/12/2025SE |
| K230689 | T-FIX 3DSI Joint Fusion SystemOUR · Special | 04/05/2023SE |
| K214123 | T-FIX® 3DSI Joint Fusion SystemOUR · Traditional | 06/24/2022SE |
| K200991 | EVOL Spinal Interbody SystemMAX · Special | 05/13/2020SE |
| K200552 | EVOS Lumbar Interbody SystemMAX · Special | 04/02/2020SE |
| K190025 | EVOL® -SI Joint Fusion SystemOUR · Traditional | 08/12/2019SE |
| K180674 | EVOL® ha-C Cervical Interbody Fusion SystemODP · Traditional | 06/25/2018SE |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemMAX · Special | 05/04/2018SE |
| K150321 | EVOS Lumbar Interbody SystemMAX · Traditional | 07/13/2015SE |
| K102957 | Cutting Edge Spine Interbody Fusion DeviceMAX · Traditional | 04/28/2011SE |
Questions and answers
When was EVOL ha - D Lateral Interbody Fusion System cleared by the FDA?
EVOL ha - D Lateral Interbody Fusion System (K192497) received a 510(k) decision of Substantially Equivalent on January 6, 2020, 117 days after the submission was received.
What is the product code of K192497?
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.