| Primary Device ID | 07630345731654 |
| NIH Device Record Key | b968e163-5752-4e8f-aff5-6cae124bf6d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NextAR Knee Platform |
| Version Model Number | 15.8010S |
| 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 | 07630345731654 [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 | 2022-03-22 |
| Device Publish Date | 2022-03-14 |
| 07630345731807 | MyKnee NextAR FemPinPositioner_Ass-CT-GMK-RM-sterile |
| 07630345731791 | MyKnee NextAR FemPinPositioner_Ass-CT-GMK-RM |
| 07630345731784 | MyKnee NextAR FemPinPositioner_Ass-CT-GMK-LM-sterile |
| 07630345731777 | MyKnee NextAR FemPinPositioner_Ass-CT-GMK-LM |
| 07630345731678 | MyKnee NextAR TibPinPositioner_Ass-CT-GMK-RM-sterile |
| 07630345731661 | MyKnee NextAR TibPinPositioner_Ass-CT-GMK-RM |
| 07630345731654 | MyKnee NextAR TibPinPositioner_Ass-CT-GMK-LM-sterile |
| 07630345731647 | MyKnee NextAR TibPinPositioner_Ass-CT-GMK-LM |