Altus Spine Interbody Fusion System
FDA 510(k) K182406 · Altus Partners, LLC
510(k) numberK182406
Submission
- Device name
- Altus Spine Interbody Fusion System
- Applicant
- Altus Partners, LLC
West Chester, PA, US - Received
- September 4, 2018
- Decision date
- February 22, 2019
- 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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| 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 |
|---|---|---|
| K243419 | Altus Spine Navigation SystemOLO · Traditional | 05/08/2025SE |
| K211027 | Altus Spine Pedicle Screw SystemNKB · Traditional | 09/16/2022SE |
| K211837 | Altus Spine Interbody Standalone Fusion SystemOVD · Traditional | 04/19/2022SE |
| K210887 | Altus Spine Sochi OCT Spinal SystemNKG · Traditional | 08/20/2021SE |
| K200922 | Altus Spine HA Pedicle Screw SystemNKB · Special | 01/26/2021SE |
| K200322 | Altus Spine Pedicle Screw SystemNKB · Traditional | 06/02/2020SE |
| K183084 | Fuji Cervical Plate SystemKWQ · Special | 05/29/2019SE |
| K181339 | Altus Spine Pedicle Screw SystemNKB · Traditional | 07/24/2018SE |
| K181281 | Altus Spine Pedicle Screw SystemNKB · Special | 06/11/2018SE |
| K170553 | Altus Spine Interbody Fusion SystemMAX · Traditional | 12/01/2017SE |
Questions and answers
When was Altus Spine Interbody Fusion System cleared by the FDA?
Altus Spine Interbody Fusion System (K182406) received a 510(k) decision of Substantially Equivalent on February 22, 2019, 171 days after the submission was received.
What is the product code of K182406?
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.