TLC Uni Knee Femoral Implant

GUDID 09348215077228

SIGNATURE ORTHOPAEDICS PTY LTD

Unicondylar knee prosthesis

• Primary Device ID: 09348215077228
• NIH Device Record Key: 306fbd20-beb5-4aa6-ba5f-327e850e4911
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLC Uni Knee Femoral Implant
• Version Model Number: 121-21-1402
• 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	09348215077228 [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 Femoral Implant]

• 09348215077266: 121-21-1602
• 09348215077259: 121-21-1601
• 09348215077242: 121-21-1502
• 09348215077235: 121-21-1501
• 09348215077228: 121-21-1402
• 09348215077211: 121-21-1401
• 09348215077204: 121-21-1302
• 09348215077198: 121-21-1301
• 09348215077181: 121-21-1202
• 09348215077174: 121-21-1201
• 09348215077167: 121-21-1102
• 09348215077150: 121-21-1101