| Primary Device ID | 07630030827013 |
| NIH Device Record Key | 35f80150-a6ba-4334-b420-5453ce16d56f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMK Sphere Total Knee System |
| Version Model Number | 02.12.0614FL |
| 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 | 07630030827013 [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 | 2014-11-18 |
| 07630040707848 | GMK Sphere CR Tibial Insert #6R 14mm |
| 07630040707831 | GMK Sphere CR Tibial Insert #6L 14mm |
| 07630040707824 | GMK Sphere CR Tibial Insert #6R 13mm |
| 07630040707817 | GMK Sphere CR Tibial Insert #6L 13mm |
| 07630040707800 | GMK Sphere CR Tibial Insert #6R 12mm |
| 07630040707794 | GMK Sphere CR Tibial Insert #6L 12mm |
| 07630040707787 | GMK Sphere CR Tibial Insert #6R 11mm |
| 07630040707770 | GMK Sphere CR Tibial Insert #6L 11mm |
| 07630040707763 | GMK Sphere CR Tibial Insert #6R 10mm |
| 07630040707756 | GMK Sphere CR Tibial Insert #6L 10mm |
| 07630040707701 | GMK Sphere CR Tibial Insert #5R 14mm |
| 07630040707695 | GMK Sphere CR Tibial Insert #5L 14mm |
| 07630040707688 | GMK Sphere CR Tibial Insert #5R 13mm |
| 07630040707671 | GMK Sphere CR Tibial Insert #5L 13mm |
| 07630040707664 | GMK Sphere CR Tibial Insert #5R 12mm |
| 07630040707657 | GMK Sphere CR Tibial Insert #5L 12mm |
| 07630040707640 | GMK Sphere CR Tibial Insert #5R 11mm |
| 07630040707633 | GMK Sphere CR Tibial Insert #5L 11mm |
| 07630040707626 | GMK Sphere CR Tibial Insert #5R 10mm |
| 07630040707619 | GMK Sphere CR Tibial Insert #5L 10mm |
| 07630040707565 | GMK Sphere CR Tibial Insert #4R 14mm |
| 07630040707558 | GMK Sphere CR Tibial Insert #4L 14mm |
| 07630040707541 | GMK Sphere CR Tibial Insert #4R 13mm |
| 07630040707534 | GMK Sphere CR Tibial Insert #4L 13mm |
| 07630040707527 | GMK Sphere CR Tibial Insert #4R 12mm |
| 07630040707510 | GMK Sphere CR Tibial Insert #4L 12mm |
| 07630040707503 | GMK Sphere CR Tibial Insert #4R 11mm |
| 07630040707497 | GMK Sphere CR Tibial Insert #4L 11mm |
| 07630040707480 | GMK Sphere CR Tibial Insert #4R 10mm |
| 07630040707473 | GMK Sphere CR Tibial Insert #4L 10mm |
| 07630040707428 | GMK Sphere CR Tibial Insert #3R 14mm |
| 07630040707411 | GMK Sphere CR Tibial Insert #3L 14mm |
| 07630040707404 | GMK Sphere CR Tibial Insert #3R 13mm |
| 07630040707398 | GMK Sphere CR Tibial Insert #3L 13mm |
| 07630040707381 | GMK Sphere CR Tibial Insert #3R 12mm |
| 07630040707374 | GMK Sphere CR Tibial Insert #3L 12mm |
| 07630040707367 | GMK Sphere CR Tibial Insert #3R 11mm |
| 07630040707350 | GMK Sphere CR Tibial Insert #3L 11mm |
| 07630040707343 | GMK Sphere CR Tibial Insert #3R 10mm |
| 07630040707336 | GMK Sphere CR Tibial Insert #3L 10mm |
| 07630040707282 | GMK Sphere CR Tibial Insert #2R 14mm |
| 07630040707275 | GMK Sphere CR Tibial Insert #2L 14mm |
| 07630040707268 | GMK Sphere CR Tibial Insert #2R 13mm |
| 07630040707251 | GMK Sphere CR Tibial Insert #2L 13mm |
| 07630040707244 | GMK Sphere CR Tibial Insert #2R 12mm |
| 07630040707237 | GMK Sphere CR Tibial Insert #2L 12mm |
| 07630040707220 | GMK Sphere CR Tibial Insert #2R 11mm |
| 07630040707213 | GMK Sphere CR Tibial Insert #2L 11mm |
| 07630040707206 | GMK Sphere CR Tibial Insert #2R 10mm |
| 07630040707190 | GMK Sphere CR Tibial Insert #2L 10mm |