| Primary Device ID | 07630030877131 |
| NIH Device Record Key | 4e83dff4-fea6-4e70-901f-24ebb44d1c38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMK-Revision/Hinge Total Knee System |
| Version Model Number | 02.07.112FDA |
| 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 | 07630030877131 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-31 |
| 07630030888977 | Femoral Augmentation distal # 6/20 mm |
| 07630030888960 | Femoral Augmentation distal # 6/16 mm |
| 07630030888953 | Femoral Augmentation distal # 5/20 mm |
| 07630030888946 | Femoral Augmentation distal # 5/16 mm |
| 07630030888939 | Femoral Augmentation distal # 4/20 mm |
| 07630030888922 | Femoral Augmentation distal # 4/16 mm |
| 07630030888915 | Femoral Augmentation distal # 3/20 mm |
| 07630030888908 | Femoral Augmentation distal # 3/16 mm |
| 07630030888892 | Femoral Augmentation distal # 2/20 mm |
| 07630030888885 | Femoral Augmentation distal # 2/16 mm |
| 07630030888878 | Femoral Augmentation distal # 1/20 mm |
| 07630030888861 | Femoral Augmentation distal # 1/16 mm |
| 07630030885501 | Femoral Augmentation distal # 6/12 mm |
| 07630030885495 | Femoral Augmentation distal # 5/12 mm |
| 07630030885488 | Femoral Augmentation distal # 4/12 mm |
| 07630030885129 | Femoral Augmentation distal # 3/12 mm |
| 07630030879524 | UC Fixed tibial insert #6/26 mm |
| 07630030879517 | UC Fixed tibial insert #6/23 mm |
| 07630030879500 | UC Fixed tibial insert #6/20 mm |
| 07630030879494 | UC Fixed tibial insert #6/17 mm |
| 07630030879487 | UC Fixed tibial insert #6/14 mm |
| 07630030879470 | UC Fixed tibial insert #6/12 mm |
| 07630030879456 | UC Fixed tibial insert #5/26 mm |
| 07630030879449 | UC Fixed tibial insert #5/23 mm |
| 07630030879432 | UC Fixed tibial insert #5/20 mm |
| 07630030879425 | UC Fixed tibial insert #5/17 mm |
| 07630030879418 | UC Fixed tibial insert #5/14 mm |
| 07630030879401 | UC Fixed tibial insert #5/12 mm |
| 07630030879388 | UC Fixed tibial insert #4/26 mm |
| 07630030879371 | UC Fixed tibial insert #4/23 mm |
| 07630030879364 | UC Fixed tibial insert #4/20 mm |
| 07630030879357 | UC Fixed tibial insert #4/17 mm |
| 07630030879340 | UC Fixed tibial insert #4/14 mm |
| 07630030879333 | UC Fixed tibial insert #4/12 mm |
| 07630030879319 | UC Fixed tibial insert #3/26 mm |
| 07630030879302 | UC Fixed tibial insert #3/23 mm |
| 07630030879296 | UC Fixed tibial insert #3/20 mm |
| 07630030879289 | UC Fixed tibial insert #3/17 mm |
| 07630030879272 | UC Fixed tibial insert #3/14 mm |
| 07630030879265 | UC Fixed tibial insert #3/12 mm |
| 07630030879241 | UC Fixed tibial insert #2/26 mm |
| 07630030879234 | UC Fixed tibial insert #2/23 mm |
| 07630030879227 | UC Fixed tibial insert #2/20 mm |
| 07630030879210 | UC Fixed tibial insert #2/17 mm |
| 07630030879203 | UC Fixed tibial insert #2/14 mm |
| 07630030879197 | UC Fixed tibial insert #2/12 mm |
| 07630030879173 | UC Fixed tibial insert #1/26 mm |
| 07630030879166 | UC Fixed tibial insert #1/23 mm |
| 07630030879159 | UC Fixed tibial insert #1/20 mm |
| 07630030879142 | UC Fixed tibial insert #1/17 mm |