K251532

Substantially Equivalent

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant: Mighty Oak Medical
Product code: LLZ
Advisory panel: Radiology
Date received: 2025-05-19
Decision date: 2025-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.