TalarLift TN-TR-0005

GUDID 00819034023240

Tray

FUSION ORTHOPEDICS, LLC

Instrument tray, reusable

• Primary Device ID: 00819034023240
• NIH Device Record Key: c502e412-8979-4659-b630-d1c3d1da6320
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TalarLift
• Version Model Number: TN-TR-0005
• Catalog Number: TN-TR-0005
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: true
• 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	00819034023240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170624

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

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

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

[00819034023240]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-27
• Device Publish Date: 2025-05-19

Devices Manufactured by FUSION ORTHOPEDICS, LLC

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• 00840124514133 - TopLock: 2025-10-03 Tap and Drill Sleeve 3.5mm
• 00840124514140 - TopLock: 2025-10-03 Tap and Drill Sleeve 4.75mm
• 00840124521551 - FuzeFix Max FT: 2025-09-25 Chamfered Screw Jig Drill Guide Sleeve 2.6mm Left
• 00840124521568 - FuzeFix Max FT: 2025-09-25 Chamfered Screw Jig Drill Guide Sleeve 3.1mm Left
• 00840124521575 - FuzeFix Max FT: 2025-09-25 Chamfered Screws Jig Wire Sleeve 1.4mm
• 00840124521582 - FuzeFix Max FT: 2025-09-25 Chamfered Screw Jig Wire Sleeve 1.6mm
• 00840124521599 - FuzeFix Max FT: 2025-09-25 Chamfered Screw K-Wire 200mm (1.4mm)