M-ARS ACL: Anatomic Ribbon Surgery System

GUDID 07630040715744

Tibial Pull Suture Plate (PSP)

Medacta International SA

Ligament bone anchor

• Primary Device ID: 07630040715744
• NIH Device Record Key: 5efc6bb8-3f01-4cd2-859e-bcb584ab2cb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-ARS ACL: Anatomic Ribbon Surgery System
• Version Model Number: 05.05.0001
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630040715744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171640

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2017-10-28

On-Brand Devices [M-ARS ACL: Anatomic Ribbon Surgery System]

• 07630040715751: Femoral Button
• 07630040715744: Tibial Pull Suture Plate (PSP)