Cleared Traditional

Luna? Ti Interbody Fusion System

K250773 · Spinal Elements, Inc. · Orthopedic

Feb 2026

Decision

327d

Days

Class 2

Risk

About This 510(k) Submission

K250773 is an FDA 510(k) clearance for the Luna? Ti Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 4, 2026, 327 days after receiving the submission on March 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250773 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	February 04, 2026
Days to Decision	327 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.