Atlas Spine Expandable Interbody System
FDA 510(k) K162918 · Atlas Spine, Inc.
510(k) numberK162918
Submission
- Device name
- Atlas Spine Expandable Interbody System
- Applicant
- Atlas Spine, Inc.
Jupiter, FL, US - Received
- October 18, 2016
- Decision date
- February 9, 2017
- 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 |
|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | 11/10/2025SE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemMAX · Traditional | 08/15/2025SE |
| K243191 | Atlas Spine Lateral Expandable Interbody SystemOVD · Traditional | 11/26/2024SE |
| K202302 | Atlas Spine Rebar (Ti) Spacer SystemODP · Traditional | 10/30/2020SE |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody SystemOVE · Traditional | 02/28/2020SE |
| K182418 | V3 Segmental Plating SystemKWQ · Traditional | 11/29/2018SE |
| K180675 | Atlas Spine Expandable Cervical Interbody SystemODP · Traditional | 06/13/2018SE |
| K172334 | Ortus Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 10/25/2017SE |
| K112759 | Apclo Pedicle Screw SystemsNKB · Special | 10/18/2011SE |
Questions and answers
When was Atlas Spine Expandable Interbody System cleared by the FDA?
Atlas Spine Expandable Interbody System (K162918) received a 510(k) decision of Substantially Equivalent on February 9, 2017, 114 days after the submission was received.
What is the product code of K162918?
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.