Luna® Ti Interbody Fusion System— 510(k) K250773

Name: FDA 510(k) clearance K250773
Creator: U.S. Food and Drug Administration
Published: 2026-02-04

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K250773 for Luna® Ti Interbody Fusion System, Substantially Equivalent on 2026-02-04. Applicant: Spinal Elements, Inc.. Device class: 2.

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-03-14
Decision date: 2026-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Spinal Elements, Inc.

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K260506 — Ventana® P/T Lumbar Interbody System2026-05-15
K253559 — Ventana A Anterior Lumbar Interbody System2026-02-25
K242527 — The Karma® Fixation System2025-05-21
K243916 — Primus Spinal Fixation System2025-02-21
K231593 — Sapphire X3 Anterior Cervical Plate System2023-08-02

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.