SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides— 510(k) K163156

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K163156 for SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, Substantially Equivalent on 2017-01-18. Applicant: Materialise NV.

Clearance details

Applicant: Materialise NV
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2016-11-10
Decision date: 2017-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.