MAX — Intervertebral Fusion Device With Bone Graft, Lumbar Class II
FDA product code MAX covers "Intervertebral Fusion Device With Bone Graft, Lumbar", a Class II medical device regulated under 21 CFR 888.3080. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MAX
- Device Class
- Class II
- Regulation Number
- 888.3080
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261049 | Spineart | SCALA® TL | Aug 20, 2026 |
| K261430 | Life Spine | TruLift Expandable System | Jul 28, 2026 |
| K253011 | Medtronic Sofamor Danek Usa | Catalyft PL Expandable Interbody System | Jul 17, 2026 |
| K261020 | Medtronic Sofamor Danek Usa | Symmetrix L Spinal System | Jul 14, 2026 |
| K253420 | Seaspine Orthopedics Corporation | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space | Jul 1, 2026 |
| K253151 | Beijing Fule Science And Technology Development Co | Fule Interbody Fusion Cage System | Jun 15, 2026 |
| K261159 | Spine Wave | Exceed® Biplanar Expandable Interbody System | May 29, 2026 |
| K253894 | Global Biomedica S.R.O | BMD Titanium Spinal Fusion System | May 28, 2026 |
| K260506 | Spinal Elements | Ventana® P/T Lumbar Interbody System | May 15, 2026 |
| K260837 | Life Spine | VersaLift Expandable System | May 12, 2026 |
| K260385 | Carlsmed | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran | May 9, 2026 |
| K261067 | Ngmedical | BEE PLIF Cage | Apr 30, 2026 |
| K254017 | Implanet | SWINGO-3D Lumbar Cage System | Feb 26, 2026 |
| K253583 | Xenix Medical | LUX Expandable Lumbar Interbody System | Feb 23, 2026 |
| K250773 | Spinal Elements | Luna® Ti Interbody Fusion System | Feb 4, 2026 |
| K253748 | Life Spine | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac | Jan 23, 2026 |
| K253266 | Spine Innovation | Titanium Interbody System | Jan 8, 2026 |
| K253577 | Medicrea International S.A.S. (Medtronic) | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Dec 19, 2025 |
| K252610 | Zsfab | ZSFab Lumbar Interbody System | Nov 25, 2025 |
| K252351 | Cg Medtech Co | UniSpace® TPLIF Cage | Oct 28, 2025 |