| Primary Device ID | 07630040711654 |
| NIH Device Record Key | 16785d8f-e68c-47c8-b4e9-d9309b8bfcdc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMK Total Knee System |
| Version Model Number | 02.12.28T4I3R |
| 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 | 07630040711654 [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 | 2021-01-01 |
| Device Publish Date | 2020-12-24 |
| 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 |