| Primary Device ID | 09348215146788 |
| NIH Device Record Key | ecb95446-4650-43fb-884d-492750ea4aaf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rx Knee All Poly Half Augment– UHMWPE - 12mm Size 1 |
| Version Model Number | 121-20-9361 |
| Company DUNS | 751993028 |
| Company Name | SIGNATURE ORTHOPAEDICS PTY LTD |
| 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 | true |
| 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 |