AEQUALIS HUMERAL PLATE

GUDID 03700386928819

TORNIER

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: 03700386928819
• NIH Device Record Key: 4c7e521d-b422-4fa3-827a-b535554d7fbf
• Commercial Distribution Discontinuation: 2018-10-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AEQUALIS HUMERAL PLATE
• Version Model Number: DWD010
• Company DUNS: 260324876
• Company Name: TORNIER
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com

Device Dimensions

• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386928819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060545

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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: 2020-06-11
• Device Publish Date: 2015-10-16

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• 03700434023701 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023718 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023725 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023732 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Bone Model
• 03700434023817 - Aequalis Reversed II: 2024-05-30 Hexagonal Tip AO
• 03700386999345 - Aequalis Reversed II: 2024-05-02 Silicone Pad
• 03700386999352 - Tornier Perform Anatomic Glenoid: 2024-05-02 Lid