Acetabular Cup Orientation System— 510(k) K150780

Name: FDA 510(k) clearance K150780
Creator: U.S. Food and Drug Administration
Published: 2015-10-27

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K150780 for Acetabular Cup Orientation System, Substantially Equivalent on 2015-10-27. Applicant: Materialise NV. Device class: 2.

Clearance details

Applicant: Materialise NV
Product code: Code PLW
Device class: Class 2
Regulation: 21 CFR 888.3350
Advisory panel: Orthopedic
Date received: 2015-03-25
Decision date: 2015-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

More clearances from Materialise NV

view all

K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner2026-06-09
K251964 — Mimics Thoracic Planner2026-03-12
K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models2026-01-07
K253793 — Materialise TKA Guide System2026-01-06
K251554 — Materialise TKA Guide System2025-07-14

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