Materialise PKA Guide System— 510(k) K202207

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K202207 for Materialise PKA Guide System, Substantially Equivalent on 2020-10-02. Applicant: Materialise NV.

Clearance details

Applicant: Materialise NV
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2020-08-06
Decision date: 2020-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.