ACO Planner ACO Planner

GUDID E314ACOPLANNER0

ACO Planner

Materialise NV

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

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