Luna 3D Interbody Fusion System— 510(k) K162431

Name: FDA 510(k) clearance K162431
Creator: U.S. Food and Drug Administration
Published: 2016-11-17

Substantially Equivalent

Benvenue Medical, Inc.

FDA 510(k) clearance K162431 for Luna 3D Interbody Fusion System, Substantially Equivalent on 2016-11-17. Applicant: Benvenue Medical, Inc.. Device class: 2.

Clearance details

Applicant: Benvenue Medical, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2016-08-31
Decision date: 2016-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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K141141 — KIVA VCF TREATMENT SYSTEM2014-08-14

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.