GMK Sphere Revision System

GUDID 07630345718792

GMK Sphere Revision Distal Wedge S3/4 20mm

Medacta International SA

Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge

• Primary Device ID: 07630345718792
• NIH Device Record Key: 881199c3-cd19-46fa-8541-d416d4105e68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK Sphere Revision System
• Version Model Number: 02.19.DB20
• 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	07630345718792 [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