TalarLift™ STS TL-CY-0012-S

GUDID 00819034027385

Cylindrical ST Implant 12mm (Sterile)

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00819034027385
• NIH Device Record Key: 0294101e-2246-442a-b010-35793ebf44c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TalarLift™ STS
• Version Model Number: TL-CY-0012-S
• Catalog Number: TL-CY-0012-S
• 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: 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	00819034027385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170624

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-26

On-Brand Devices [TalarLift™ STS]

• 00819034027392: Anatomical ST Implant 12mm (Sterile)
• 00819034027385: Cylindrical ST Implant 12mm (Sterile)
• 00819034027378: Conical ST Implant 12mm (Sterile)
• 00819034027361: Anatomical ST Implant 12mm
• 00819034027354: Cylindrical ST Implant 12mm
• 00819034027347: Conical ST Implant 12mm
• 00819034022533: Anatomical ST Implant 11mm (Sterile)
• 00819034022526: Anatomical ST Implant 10mm (Sterile)
• 00819034022519: Anatomical ST Implant 9mm (Sterile)
• 00819034022502: Anatomical ST Implant 8mm (Sterile)
• 00819034022496: Anatomical ST Implant 7mm (Sterile)
• 00819034022489: Cylindrical ST Implant 11mm (Sterile)
• 00819034022472: Cylindrical ST Implant 10mm (Sterile)
• 00819034022465: Cylindrical ST Implant 9mm (Sterile)
• 00819034022458: Cylindrical ST Implant 8mm (Sterile)
• 00819034022441: Cylindrical ST Implant 7mm (Sterile)
• 00819034022434: Conical ST Implant 11mm (Sterile)
• 00819034022427: Conical ST Implant 10mm (Sterile)
• 00819034022410: Conical ST Implant 8mm (Sterile)
• 00819034022403: Conical ST Implant 9mm (Sterile)
• 00819034022397: Conical ST Implant 7mm (Sterile)
• 00819034022380: Anatomical ST Implant 11mm
• 00819034022373: Anatomical ST Implant 10mm
• 00819034022366: Anatomical ST Implant 8mm
• 00819034022359: Anatomical ST Implant 9mm
• 00819034022342: Anatomical ST Implant 7mm
• 00819034022335: Cylindrical ST Implant 11mm
• 00819034022328: Cylindrical ST Implant 10mm
• 00819034022311: Cylindrical ST Implant 9mm
• 00819034022304: Cylindrical ST Implant 8mm
• 00819034022298: Cylindrical ST Implant 7mm
• 00819034022281: Conical ST Implant 11mm
• 00819034022274: Conical ST Implant 10mm
• 00819034022267: Conical ST Implant 9mm
• 00819034022250: Conical ST Implant 8mm
• 00819034022243: Conical ST Implant 7mm
• 00819034022229: (not in use)
• 00819034022212: (not in use)
• 00819034022205: (not in use)
• 00819034022199: (not in use)
• 00819034022182: (not in use)
• 00819034022175: (not in use)
• 00819034022168: (not in use)
• 00819034022151: (not in use)
• 00819034022021: (not in use)
• 00819034021611: (not in use)