GMK Total Knee System

GUDID 07630345716422

Femoral Component SPHERIKA TiNbN coated Cemented S7R

Medacta International SA

Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis

• Primary Device ID: 07630345716422
• NIH Device Record Key: 49e9a704-4b3f-44cb-8e7b-5f6c1d1ae5f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK Total Knee System
• Version Model Number: 02.12.KA27R
• 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	07630345716422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211004

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: 2021-08-13
• Device Publish Date: 2021-08-05

On-Brand Devices [GMK Total Knee System]

• 07630040711654: GMK Sphere Tibial tray fixed cemented #t4i3 R TiNbN coated
• 07630040711647: GMK Sphere Tibial tray fixed cemented #t4i3 L TiNbN coated
• 07630040711630: GMK Sphere Tibial tray fixed cemented #t3i4 R TiNbN coated
• 07630040711623: GMK Sphere Tibial tray fixed cemented #t3i4 L TiNbN coated
• 07630040711616: Femoral Component Sphere #6+ R TiNbN coated
• 07630040711609: Femoral Component Sphere #6+ L TiNbN coated
• 07630040711593: Femoral Component Sphere #5+ R TiNbN coated
• 07630040711586: Femoral Component Sphere #5+ L TiNbN coated
• 07630040711579: Femoral Component Sphere #4+ R TiNbN coated
• 07630040711562: Femoral Component Sphere #4+ L TiNbN coated
• 07630040711555: Femoral Component Sphere #3+ R TiNbN coated
• 07630040711548: Femoral Component Sphere #3+ L TiNbN coated
• 07630040711531: Femoral Component Sphere #2+ R TiNbN coated
• 07630040711524: Femoral Component Sphere #2+ L TiNbN coated
• 07630040711517: Femoral Component Sphere #1+ R TiNbN coated
• 07630040711500: Femoral Component Sphere #1+ L TiNbN coated
• 07630040711494: Femoral Component Sphere #7 R TiNbN coated
• 07630040711487: Femoral Component Sphere #7 L TiNbN coated
• 07630040711470: Femoral Component Sphere #6 R TiNbN coated
• 07630040711463: Femoral Component Sphere #6 L TiNbN coated
• 07630040711456: Femoral Component Sphere #5 R TiNbN coated
• 07630040711449: Femoral Component Sphere #5 L TiNbN coated
• 07630040711432: Femoral Component Sphere #4 R TiNbN coated
• 07630040711425: Femoral Component Sphere #4 L TiNbN coated
• 07630040711418: Femoral Component Sphere #3 R TiNbN coated
• 07630040711401: Femoral Component Sphere #3 L TiNbN coated
• 07630040711395: Femoral Component Sphere #2 R TiNbN coated
• 07630040711388: Femoral Component Sphere #2 L TiNbN coated
• 07630040711371: Femoral Component Sphere #1 R TiNbN coated
• 07630040711364: Femoral Component Sphere #1 L TiNbN coated
• 07630030821875: Tibial tray fixed cemented #6 R TiNbN coated
• 07630030821868: Tibial tray fixed cemented #6 L TiNbN coated
• 07630030821851: Tibial tray fixed cemented #5 R TiNbN coated
• 07630030821844: Tibial tray fixed cemented #5 L TiNbN coated
• 07630030821837: Tibial tray fixed cemented #4 R TiNbN coated
• 07630030821820: Tibial tray fixed cemented #4 L TiNbN coated
• 07630030821813: Tibial tray fixed cemented #3 R TiNbN coated
• 07630030821806: Tibial tray fixed cemented #3 L TiNbN coated
• 07630030821790: Tibial tray fixed cemented #2 R TiNbN coated
• 07630030821783: Tibial tray fixed cemented #2 L TiNbN coated
• 07630030821776: Tibial tray fixed cemented #1 R TiNbN coated
• 07630030821769: Tibial tray fixed cemented #1 L TiNbN coated
• 07630345716194: Femoral Component SPHERIKA Cemented S2+L
• 07630345716187: Femoral Component SPHERIKA Cemented S1+R
• 07630345716170: Femoral Component SPHERIKA Cemented S1+L
• 07630345716163: Femoral Component SPHERIKA Cemented S7R
• 07630345716330: Femoral Component SPHERIKA TiNbN coated Cemented S3L
• 07630345716323: Femoral Component SPHERIKA TiNbN coated Cemented S2R
• 07630345716316: Femoral Component SPHERIKA TiNbN coated Cemented S2L
• 07630345716309: Femoral Component SPHERIKA TiNbN coated Cemented S1R