K110415

Substantially Equivalent

SIGNATURE PLANNER / SIGNATURE GUIDES

Applicant: Materialise NV
Product code: HRY
Advisory panel: Orthopedic
Date received: 2011-02-14
Decision date: 2011-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.