Align Lumbar Interbody Fusion System
FDA 510(k) K221535 · Acuity Surgical Devices, LLC
510(k) numberK221535
Submission
- Device name
- Align Lumbar Interbody Fusion System
- Applicant
- Acuity Surgical Devices, LLC
Irving, TX, US - Received
- May 27, 2022
- Decision date
- July 22, 2022
- 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 |
|---|---|---|
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs)OVE · Traditional | 07/30/2025SE |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs)MAX · Traditional | 06/02/2025SE |
| K243386 | Ventris Intervertebral Body Fusion DeviceOVD · Traditional | 04/22/2025SE |
| K241413 | sagAlign Lumbar Cage System (Various PNs)MAX · Traditional | 07/17/2024SE |
| K230639 | Align Cervical Interbody Fusion SystemODP · Traditional | 12/01/2023SE |
| K222561 | AlignOVD · Special | 09/23/2022SE |
| K201671 | A-Link ZOVD · Traditional | 05/04/2021SE |
Questions and answers
When was Align Lumbar Interbody Fusion System cleared by the FDA?
Align Lumbar Interbody Fusion System (K221535) received a 510(k) decision of Substantially Equivalent on July 22, 2022, 56 days after the submission was received.
What is the product code of K221535?
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.