TruMatch CMF Titanium 3D Printed Implant— 510(k) K173039
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K173039 for TruMatch CMF Titanium 3D Printed Implant, Substantially Equivalent on 2018-07-10. Applicant: Materialise NV. Device class: 2.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code JEY
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
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More clearances from Materialise NV
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- K251964 — Mimics Thoracic 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
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
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.