PRADO Lumbar Interbody Fusion System— 510(k) K252113

Name: FDA 510(k) clearance K252113
Creator: U.S. Food and Drug Administration
Published: 2025-08-05

Substantially Equivalent

Bethesda Medical Devices

FDA 510(k) clearance K252113 for PRADO Lumbar Interbody Fusion System, Substantially Equivalent on 2025-08-05. Applicant: Bethesda Medical Devices. Device class: 2.

Clearance details

Applicant: Bethesda Medical Devices
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-07-07
Decision date: 2025-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Brunswick, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

view all

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

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.