GMK Sphere Revision System

GUDID 07630345718310

GMK Sphere Revision Femoral Component S7R TiNbN Coated

Medacta International SA

Coated knee femur prosthesis

• Primary Device ID: 07630345718310
• NIH Device Record Key: d7475c9a-a729-486e-84a8-53e74377428d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK Sphere Revision System
• Version Model Number: 02.19.017R
• 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	07630345718310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211664

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: 2021-08-25
• Device Publish Date: 2021-08-17

On-Brand Devices [GMK Sphere Revision System]

• 07630971243323: GMK Sphere Revision Femoral Component S8R
• 07630971243316: GMK Sphere Revision Femoral Component S8L
• 07630971243309: GMK Sphere Revision Femoral Component S7R
• 07630971243293: GMK Sphere Revision Femoral Component S7L
• 07630971243286: GMK Sphere Revision Femoral Component S6R
• 07630971243279: GMK Sphere Revision Femoral Component S6L
• 07630971243262: GMK Sphere Revision Femoral Component S5R
• 07630971243255: GMK Sphere Revision Femoral Component S5L
• 07630971243248: GMK Sphere Revision Femoral Component S4R
• 07630971243231: GMK Sphere Revision Femoral Component S4L
• 07630971243224: GMK Sphere Revision Femoral Component S3R
• 07630971243217: GMK Sphere Revision Femoral Component S3L
• 07630971243200: GMK Sphere Revision Femoral Component S2R
• 07630971243194: GMK Sphere Revision Femoral Component S2L
• 07630345721143: GMK Sphere Revision Offset 5mm
• 07630345721136: GMK Sphere Revision Offset 4mm
• 07630345721129: GMK Sphere Revision Offset 3mm
• 07630345721112: GMK Sphere Revision Offset 2mm
• 07630345719119: GMK Sphere Revision Tibial Tray T4I3R
• 07630345719102: GMK Sphere Revision Tibial Tray T4I3L
• 07630345719096: GMK Sphere Revision Tibial Tray T3I4R
• 07630345719089: GMK Sphere Revision Tibial Tray T3I4L
• 07630345719072: GMK Sphere Revision Posterior Wedge S8 12mm
• 07630345719065: GMK Sphere Revision Posterior Wedge S8 8mm
• 07630345719058: GMK Sphere Revision Posterior Wedge S8 4mm
• 07630345719041: GMK Sphere Revision Posterior Wedge S7 12mm
• 07630345719034: GMK Sphere Revision Posterior Wedge S7 8mm
• 07630345719027: GMK Sphere Revision Posterior Wedge S7 4mm
• 07630345719010: GMK Sphere Revision Posterior Wedge S6 12mm
• 07630345719003: GMK Sphere Revision Posterior Wedge S6 8mm
• 07630345718990: GMK Sphere Revision Posterior Wedge S6 4mm
• 07630345718983: GMK Sphere Revision Posterior Wedge S5 12mm
• 07630345718976: GMK Sphere Revision Posterior Wedge S5 8mm
• 07630345718969: GMK Sphere Revision Posterior Wedge S5 4mm
• 07630345718952: GMK Sphere Revision Posterior Wedge S3/4 12mm
• 07630345718945: GMK Sphere Revision Posterior Wedge S3/4 8mm
• 07630345718938: GMK Sphere Revision Posterior Wedge S3/4 4mm
• 07630345718921: GMK Sphere Revision Posterior Wedge S2 12mm
• 07630345718914: GMK Sphere Revision Posterior Wedge S2 8mm
• 07630345718907: GMK Sphere Revision Posterior Wedge S2 4mm
• 07630345718891: GMK Sphere Revision Distal Wedge S7/8 20mm
• 07630345718884: GMK Sphere Revision Distal Wedge S7/8 16mm
• 07630345718877: GMK Sphere Revision Distal Wedge S7/8 12mm
• 07630345718860: GMK Sphere Revision Distal Wedge S7/8 8mm
• 07630345718853: GMK Sphere Revision Distal Wedge S7/8 4mm
• 07630345718846: GMK Sphere Revision Distal Wedge S5/6 20mm
• 07630345718839: GMK Sphere Revision Distal Wedge S5/6 16mm
• 07630345718822: GMK Sphere Revision Distal Wedge S5/6 12mm
• 07630345718815: GMK Sphere Revision Distal Wedge S5/6 8mm
• 07630345718808: GMK Sphere Revision Distal Wedge S5/6 4mm