MAX — Intervertebral Fusion Device With Bone Graft, Lumbar Class II
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 |
|---|---|---|---|
| K254017 | implanet | SWINGO-3D Lumbar Cage System | February 26, 2026 |
| K253583 | xenix medical | LUX Expandable Lumbar Interbody System | February 23, 2026 |
| K250773 | spinal elements | Luna® Ti Interbody Fusion System | February 4, 2026 |
| K253748 | life spine | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac | January 23, 2026 |
| K253266 | spine innovation | Titanium Interbody System | January 8, 2026 |
| K253577 | medicrea international s.a.s. (medtronic) | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | December 19, 2025 |
| K252610 | zsfab | ZSFab Lumbar Interbody System | November 25, 2025 |
| K252351 | cg medtech co | UniSpace® TPLIF Cage | October 28, 2025 |
| K253377 | spectrum spine | Expandable Titanium PLIF/TLIF System | October 24, 2025 |
| K251479 | mobarn medical devices | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C | September 18, 2025 |
| K251444 | medtronic sofamor danek usa | Endoskeleton Interbody Systems | September 4, 2025 |
| K251969 | atlas spine | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | August 15, 2025 |
| K252113 | bethesda medical devices | PRADO Lumbar Interbody Fusion System | August 5, 2025 |
| K251016 | medacta international | MectaLIF 3D Metal | July 17, 2025 |
| K251741 | l and k biomed co | PathLoc Lumbar Interbody Fusion Cage System | July 8, 2025 |
| K251502 | life spine | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | July 7, 2025 |
| K250827 | carlsmed | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbod | July 7, 2025 |
| K250987 | carlsmed | aprevo® posterior/transforaminal lumbar interbody fusion device | June 30, 2025 |
| K243816 | spine wave | Testa TP Pivoting Spacer System | June 27, 2025 |
| K251003 | expanding innovations | X-PAC® LLIF Expandable Lateral Cage System | June 25, 2025 |