| Primary Device ID | 09348215147136 |
| NIH Device Record Key | 4e0c4870-b84f-4be1-a8f9-266b8eae0f1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rx Knee All Poly Half, 4° Draft Augment – Titanium - 8mm Size 9 Left |
| Version Model Number | 121-20-9479 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09348215147136 [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 | 2025-03-27 |
| Device Publish Date | 2025-03-19 |
| 09348215039295 - Liner Impactor | 2026-02-09 |
| 09348215039301 - Liner Impactor | 2026-02-09 |
| 09348215039318 - Liner Impactor | 2026-02-09 |
| 09348215039325 - Liner Impactor | 2026-02-09 |
| 09348215039332 - Ceramic Liner Inserter Impactor Head | 2026-02-09 |
| 09348215039349 - Ceramic Liner Inserter Impactor Head | 2026-02-09 |
| 09348215039356 - Ceramic Liner Inserter Impactor Head | 2026-02-09 |
| 09348215039363 - Ceramic Liner Inserter Impactor Head | 2026-02-09 |