| Primary Device ID | 07630345718976 |
| NIH Device Record Key | 513464cc-30f6-40b0-ba7e-ec69b40f7719 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMK Sphere Revision System |
| Version Model Number | 02.19.PC08 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07630345718976 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-25 |
| Device Publish Date | 2021-08-17 |
| 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 |