EcoFit® coxa vara trial neck for broach 133°

GUDID 04048844310165

implantcast GmbH

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844310165
• NIH Device Record Key: cf2223c5-9ffe-4f17-94dd-32b8e69848af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® coxa vara trial neck for broach 133°
• Version Model Number: 70701214
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• Device Count: 1
• DM Exempt: true
• 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
GS1	04048844310165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163577

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

[04048844310165]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-04
• Device Publish Date: 2019-03-27

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• 04048844522841 - AGILON®: 2024-02-29 metaphyseal component omarthrosis
• 04048844522858 - AGILON®: 2024-02-29 metaphyseal component omarthrosis incl. safety screw
• 04048844522865 - AGILON®: 2024-02-29 metaphyseal component omarthrosis
• 04048844522902 - AGILON®: 2024-02-29 trial metaphyseal component trauma 145°
• 04048844522919 - AGILON®: 2024-02-29 trial metaphyseal component omarthrosis 145°