Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner— 510(k) K241143

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K241143 for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Substantially Equivalent on 2024-05-22. Applicant: Materialise NV.

Clearance details

Applicant
Materialise NV
Product code
Code QHE
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Leuven, BE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.