X-Pac Expandable Lumbar Cage System
FDA 510(k) K220655 · Expanding Innovations, Inc.
510(k) numberK220655
Submission
- Device name
- X-Pac Expandable Lumbar Cage System
- Applicant
- Expanding Innovations, Inc.
Mountain View, CA, US - Received
- March 7, 2022
- Decision date
- March 24, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K251003 | X-PAC® LLIF Expandable Lateral Cage SystemMAX · Traditional | 06/25/2025SE |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemMAX · Special | 06/16/2025SE |
| K250602 | X-PAC® N-GAGE Lumbar Plate SystemKWQ · Traditional | 05/20/2025SE |
| K223174 | X-Pac Expandable LLIF Cage SystemMAX · Traditional | 02/14/2023SE |
| K222797 | X-Pac Expandable Lumbar Cage SystemMAX · Special | 10/14/2022SE |
| K203802 | X-Pac Expandable Lumbar Cage SystemMAX · Traditional | 06/07/2021SE |
| K201145 | X-Pac Expandable Lumbar Cage SystemMAX · Traditional | 09/10/2020SE |
Questions and answers
When was X-Pac Expandable Lumbar Cage System cleared by the FDA?
X-Pac Expandable Lumbar Cage System (K220655) received a 510(k) decision of Substantially Equivalent on March 24, 2022, 17 days after the submission was received.
What is the product code of K220655?
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.