TLC Uni Knee Tibial Plate

GUDID 09348215077075

SIGNATURE ORTHOPAEDICS PTY LTD

Unicondylar knee prosthesis

• Primary Device ID: 09348215077075
• NIH Device Record Key: cb8e95f6-305d-4f61-a64b-3bd9a06047ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLC Uni Knee Tibial Plate
• Version Model Number: 121-21-3301
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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	09348215077075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212870

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-08
• Device Publish Date: 2022-06-30

On-Brand Devices [TLC Uni Knee Tibial Plate]

• 09348215077143: 121-21-3602
• 09348215077136: 121-21-3601
• 09348215077129: 121-21-3502
• 09348215077112: 121-21-3501
• 09348215077105: 121-21-3402
• 09348215077099: 121-21-3401
• 09348215077082: 121-21-3302
• 09348215077075: 121-21-3301
• 09348215077068: 121-21-3202
• 09348215077051: 121-21-3201
• 09348215077044: 121-21-3102
• 09348215077037: 121-21-3101