GMK 3D Metal Tibial Tray

GUDID 07630345710932

3DMetal Tibial Tray Size 5+L

Medacta International SA

Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis Trabeculated bicondylar knee tibia prosthesis

• Primary Device ID: 07630345710932
• NIH Device Record Key: f7b6ef69-1930-458d-9ec6-e5b69dc5a757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK 3D Metal Tibial Tray
• Version Model Number: 02.12.3D55L
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630345710932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221850

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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: 2022-09-05
• Device Publish Date: 2022-08-26

On-Brand Devices [GMK 3D Metal Tibial Tray]

• 07630345710925: 3DMetal Tibial Tray Size T4I3R
• 07630345710918: 3DMetal Tibial Tray Size T4I3L
• 07630345710901: 3DMetal Tibial Tray Size T3I4R
• 07630345710895: 3DMetal Tibial Tray Size T3I4L
• 07630345710888: 3DMetal Tibial Tray Size 6R
• 07630345710871: 3DMetal Tibial Tray Size 6L
• 07630345710864: 3DMetal Tibial Tray Size 5R
• 07630345710857: 3DMetal Tibial Tray Size 5L
• 07630345710840: 3DMetal Tibial Tray Size 4R
• 07630345710833: 3DMetal Tibial Tray Size 4L
• 07630345710826: 3DMetal Tibial Tray Size 3R
• 07630345710819: 3DMetal Tibial Tray Size 3L
• 07630345710802: 3DMetal Tibial Tray Size 2R
• 07630345710796: 3DMetal Tibial Tray Size 2L
• 07630345710789: 3DMetal Tibial Tray Size 1R
• 07630345710772: 3DMetal Tibial Tray Size 1L
• 07630345717740: 3DMetal Tibial Tray Size 1+L
• 07630345717566: 3DMetal Tibial Tray Size 4+R
• 07630345717559: 3DMetal Tibial Tray Size 4+L
• 07630345717542: 3DMetal Tibial Tray Size 3+R
• 07630345717535: 3DMetal Tibial Tray Size 3+L
• 07630345717528: 3DMetal Tibial Tray Size 2+R
• 07630345717511: 3DMetal Tibial Tray Size 2+L
• 07630345717504: 3DMetal Tibial Tray Size 1+R
• 07630345710949: 3DMetal Tibial Tray Size 5+R
• 07630345710932: 3DMetal Tibial Tray Size 5+L