Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
FDA 510(k) K210044 · Spinal Elements, Inc.
510(k) numberK210044
Submission
- Device name
- Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
- Applicant
- Spinal Elements, Inc.
Carlsbad, CA, US - Received
- January 7, 2021
- Decision date
- June 30, 2021
- 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.
Other 510(k)s with product code MAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | 05/15/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | 02/25/2026SE |
| K250773 | Luna® Ti Interbody Fusion SystemMAX · Traditional | 02/04/2026SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | 05/21/2025SE |
| K243916 | Primus Spinal Fixation SystemNKB · Traditional | 02/21/2025SE |
| K234150 | Lucent® XPMAX · Traditional | 03/27/2024SE |
| K231593 | Sapphire X3 Anterior Cervical Plate SystemKWQ · Traditional | 08/02/2023SE |
| K231252 | Ventana L Spinal SystemMAX · Traditional | 06/30/2023SE |
| K222833 | Ventana C Spinal SystemODP · Traditional | 05/19/2023SE |
| K222516 | Mercury® II Spinal SystemNKB · Traditional | 12/01/2022SE |
Questions and answers
When was Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System cleared by the FDA?
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System (K210044) received a 510(k) decision of Substantially Equivalent on June 30, 2021, 174 days after the submission was received.
What is the product code of K210044?
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.