SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides— 510(k) K163156
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K163156 for SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, Substantially Equivalent on 2017-01-18. Applicant: Materialise NV. Device class: 2.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code PBF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
Recent devices under product code PBF
view allMore clearances from Materialise NV
view all- K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- 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 PBF
product code PBF- Injury
- 180
- Total
- 180
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.