Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner— 510(k) K193560

Name: FDA 510(k) clearance K193560
Creator: U.S. Food and Drug Administration
Published: 2020-03-20

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K193560 for Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner, Substantially Equivalent on 2020-03-20. 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: 2019-12-23
Decision date: 2020-03-20
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.