Mimics Thoracic Planner— 510(k) K251964
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K251964 for Mimics Thoracic Planner, Substantially Equivalent on 2026-03-12. Applicant: Materialise NV. Device class: 2.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
Recent devices under product code LLZ
view allMore clearances from Materialise NV
view all- K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- K253793 — Materialise TKA Guide System
- K251554 — Materialise TKA Guide System
- K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.