Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner— 510(k) K212569

Name: FDA 510(k) clearance K212569
Creator: U.S. Food and Drug Administration
Published: 2022-01-12

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K212569 for Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Substantially Equivalent on 2022-01-12. Applicant: Materialise NV. Device class: 2.

Clearance details

Applicant: Materialise NV
Product code: Product code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2021-08-16
Decision date: 2022-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.