DeviceClearance

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

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.

Summary

Spinal Elements' Luna® Ti Interbody Fusion System is filed under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Spinal Elements filed from Carlsbad, California. FDA found it substantially equivalent 327 calendar days after receipt (March 14, 2025 to February 4, 2026).

Clearance details

Applicant
Spinal Elements, Inc.
Product code
Product code MAX
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

Source: openFDA MAUDE database, through . 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.