TalarLift STS TN-TL-3012

GUDID 00819034027422

Trial Cylindrical 12mm

FUSION ORTHOPEDICS, LLC

Orthopaedic implant/trial-implant holder, single-use

• Primary Device ID: 00819034027422
• NIH Device Record Key: a80a42a4-8ed4-4ba2-b50b-807bc8266eb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TalarLift STS
• Version Model Number: TN-TL-3012
• Catalog Number: TN-TL-3012
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• 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: true
• 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	00819034027422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170624

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

[00819034027422]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-04-29

On-Brand Devices [TalarLift STS ]

• 00819034027422: Trial Cylindrical 12mm
• 00819034027415: Trial Anatomical 12mm
• 00819034027408: Trial Conical 12mm
• 00819034022724: Trial Cylindrical 11mm
• 00819034022717: Trial Cylindrical 10mm
• 00819034022700: Trial Cylindrical 9mm
• 00819034022694: Trial Cylindrical 8mm
• 00819034022687: Trial Cylindrical 7mm
• 00819034022663: Trial Anatomical 10mm
• 00819034022656: Trial Anatomical 9mm
• 00819034022649: Trial Anatomical 8mm
• 00819034022632: Trial Anatomical 7mm
• 00819034022625: Trial Conical 11mm
• 00819034022618: Trial Conical 10mm
• 00819034022601: Trial Conical 9mm
• 00819034022595: Trial Conical 8mm
• 00819034022588: Trial Conical 7mm
• 00819034022571: Probe 5.0mm
• 00819034022564: Driver STS 131mm
• 00819034022557: Removal Driver STS 131mm
• 00819034022540: CoCR Implant Rod
• 00840124505100: STS Removal Driver Cannulated