Uni FB tibial component LM/RL

GUDID 04048844205362

implantcast GmbH

Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic Uncoated unicondylar knee tibia prosthesis, metallic

• Primary Device ID: 04048844205362
• NIH Device Record Key: 8c1d277b-7777-4ee6-b8b0-aab74ddd02f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni FB tibial component LM/RL
• Version Model Number: 40100021
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844205362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203341

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: 2021-01-20
• Device Publish Date: 2021-01-12

On-Brand Devices [Uni FB tibial component LM/RL]

• 04048844480073: 40100027
• 04048844480066: 40100026
• 04048844480059: 40100020
• 04048844205393: 40100024
• 04048844205386: 40100023
• 04048844205379: 40100022
• 04048844205362: 40100021