Chrysalis Intelligence · Product Codes · MAX

MAX · Intervertebral Fusion Device With Bone Graft, Lumbar

Orthopedic · 263 clearances · 114 unique sponsors

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Device class
Class II
Regulation 888.3080
Total clearances
263
2020-01-06 → 2026-07-28
Last 12 months
22
Unique sponsors
114
Definition

What is Intervertebral Fusion Device With Bone Graft, Lumbar

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Classification details
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3080
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Life Spine, Inc. 18 3 2026-07-28
SeaSpine Orthopedics Corporation 15 1 2026-07-01
Alphatec Spine, Inc. 12 0 2025-02-03
Medtronic Sofamor Danek USA, Inc. 12 3 2026-07-17
Carlsmed, Inc. 11 1 2026-05-09
Nu Vasive, Incorporated 9 0 2022-06-21
Spinal Elements, Inc. 7 2 2026-05-15
Expanding Innovations, Inc. 7 0 2025-06-25
Zavation Medical Products, LLC 6 0 2024-04-10
Degen Medical 6 0 2025-04-04
Integrity Implants, Inc. 5 0 2022-03-25
L&K BIOMED Co., Ltd. 5 0 2025-07-08
Ctl Medical Corporation 4 0 2024-10-10
Enztec Limited 4 0 2023-09-01
Vy Spine, LLC 4 0 2025-03-18
Globus Medical, Inc. 4 0 2024-09-06
Camber Spine Technologies, LLC 3 0 2024-07-12
Astura Medical, LLC 3 0 2023-05-09
Acuity Surgical Devices, LLC 3 0 2025-06-02
Spectrum Spine, LLC 3 1 2025-10-24
Medacta International S.A. 3 0 2025-07-17
Spine Wave, Inc. 3 1 2026-05-29
NGMedical GmbH 3 1 2026-04-30
Nexxt Spine, LLC 3 0 2020-05-21
Nvision Biomedical Technologies, Inc. 3 0 2024-09-17
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
22623 CPT — High CPT code for arthrodesis, vertebral body resection, anterior approach with structural autograft/allograft or cage in lumbar region
22612 CPT — Medium CPT code for anterior or anterolateral arthrodesis, lumbar, with interbody bone graft
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-28 K261430 Life Spine, Inc. TruLift Expandable System
2026-07-17 K253011 Medtronic Sofamor Danek USA, Inc. Catalyft PL Expandable Interbody System
2026-07-14 K261020 Medtronic Sofamor Danek USA, Inc. Symmetrix™ L Spinal System
2026-07-01 K253420 SeaSpine Orthopedics Corporation Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy
2026-06-15 K253151 Beijing Fule Science & Technology Development Co., Ltd. Fule Interbody Fusion Cage System
2026-05-29 K261159 Spine Wave, Inc. Exceed® Biplanar Expandable Interbody System
2026-05-28 K253894 Global Biomedica s.r.o. BMD Titanium Spinal Fusion System
2026-05-15 K260506 Spinal Elements, Inc. Ventana® P/T Lumbar Interbody System
2026-05-12 K260837 Life Spine, Inc. VersaLift Expandable System
2026-05-09 K260385 Carlsmed, Inc. aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system
2026-04-30 K261067 NGMedical GmbH BEE PLIF Cage
2026-02-26 K254017 Implanet SWINGO-3D Lumbar Cage System
2026-02-23 K253583 Xenix Medical LUX Expandable Lumbar Interbody System
2026-02-04 K250773 Spinal Elements, Inc. Luna® Ti Interbody Fusion System
2026-01-23 K253748 Life Spine, Inc. Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
2026-01-08 K253266 Spine Innovation, LLC Titanium Interbody System
2025-12-19 K253577 Medicrea International S.A.S. (Medtronic) IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
2025-11-25 K252610 Zsfab, Inc. ZSFab Lumbar Interbody System
2025-10-28 K252351 Cg Medtech Co., Ltd. UniSpace® TPLIF Cage
2025-10-24 K253377 Spectrum Spine, Inc. Expandable Titanium PLIF/TLIF System
2025-09-18 K251479 Mobarn Medical Devices, LLC Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))
2025-09-04 K251444 Medtronic Sofamor Danek USA, Inc. Endoskeleton™ Interbody Systems
2025-08-15 K251969 Atlas Spine, Inc. Atlas Spine Project X Expandable Posterior Lumbar Interbody System
2025-08-05 K252113 Bethesda Medical Devices PRADO™ Lumbar Interbody Fusion System
2025-07-17 K251016 Medacta International S.A. MectaLIF 3D Metal
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence