ACO Planner ACO Planner

GUDID E314ACOPLANNER0

ACO Planner

Materialise NV

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software

• Primary Device ID: E314ACOPLANNER0
• NIH Device Record Key: b203782d-8f3b-4e82-93cb-a309fb4aec7f
• Commercial Distribution Discontinuation: 2019-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACO Planner
• Version Model Number: ACO Planner
• Catalog Number: ACO Planner
• Company DUNS: 373139427
• Company Name: Materialise NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E314ACOPLANNER0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150780

FDA Product Code

• PLW: Acetabular Cup Orientation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-16
• Device Publish Date: 2017-02-10

Devices Manufactured by Materialise NV

• 05404028000571 - Mimics Cardiac Planner: 2024-03-25 Mimics Cardiac Planner
• 05420060367052 - AtlasPlan: 2023-12-27 Bone model for Reverse Shoulder Arthroplasty Aetos
• 05420060367069 - AtlasPlan: 2023-12-27 Guide and Bone model for Reverse Shoulder Arthroplasty Aetos
• 05420060367076 - AtlasPlan: 2023-12-27 Guide for Reverse Shoulder Arthroplasty Aetos
• 05420060367083 - AtlasPlan: 2023-12-27 Guide and Bone model for Total Shoulder Arthroplasty Aetos
• 05420060367090 - AtlasPlan: 2023-12-27 Guide for Total Shoulder Arthroplasty Aetos
• 05420060367106 - AtlasPlan: 2023-12-27 Bone model for Total Shoulder Arthroplasty Aetos
• 05404028000724 - Mimics: 2023-12-26 Mimics Automatic Algorithms Ankle CT