GMK 3D Metal Tibial Tray

GUDID 07630345710796

3DMetal Tibial Tray Size 2L

Medacta International SA

Trabeculated bicondylar knee tibia prosthesis

• Primary Device ID: 07630345710796
• NIH Device Record Key: a25ed7b2-91bc-4561-86ee-d5d1b0f4b6cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK 3D Metal Tibial Tray
• Version Model Number: 02.12.3D02L
• 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	07630345710796 [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: 2022-09-02
• Device Publish Date: 2022-08-25

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