| Primary Device ID | 05055455503663 |
| NIH Device Record Key | d1a9b80d-cf13-453d-a24d-016b594e63a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medial Rotation Knee |
| Version Model Number | 156-383 |
| Catalog Number | 156-383 |
| Company DUNS | 216819863 |
| Company Name | MATORTHO 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 | 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 | 05055455503663 [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 | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2015-05-12 |
| 05055455504882 | Medial Rotation Knee Patella Reduced Thickness 25mm |
| 05055455504875 | Medial Rotation Knee Patella Reduced Thickness 20mm |
| 05055455504868 | Medial Rotation Knee Patella 30mm |
| 05055455503984 | Medial Rotation Knee Right Tibial Insert Size 3 18mm |
| 05055455503977 | Medial Rotation Knee Right Tibial Insert Size 3 15.5mm |
| 05055455503960 | Medial Rotation Knee Right Tibial Insert Size 3 13mm |
| 05055455503953 | Medial Rotation Knee Right Tibial Insert Size 3 10.5mm |
| 05055455503939 | Medial Rotation Knee Right Tibial Insert Size 2 18mm |
| 05055455503922 | Medial Rotation Knee Right Tibial Insert Size 2 15.5mm |
| 05055455503915 | Medial Rotation Knee Right Tibial Insert Size 2 13mm |
| 05055455503908 | Medial Rotation Knee Right Tibial Insert Size 2 10.5mm |
| 05055455503885 | Medial Rotation Knee Right Tibial Insert Size 1 18mm |
| 05055455503878 | Medial Rotation Knee Right Tibial Insert Size 1 15.5mm |
| 05055455503861 | Medial Rotation Knee Right Tibial Insert Size 1 13mm |
| 05055455503854 | Medial Rotation Knee Right Tibial Insert Size 1 10.5mm |
| 05055455503830 | Medial Rotation Knee Left Tibial Insert Size 3 18mm |
| 05055455503823 | Medial Rotation Knee Left Tibial Insert Size 3 15.5mm |
| 05055455503816 | Medial Rotation Knee Left Tibial Insert Size 3 13mm |
| 05055455503809 | Medial Rotation Knee Left Tibial Insert Size 3 10.5mm |
| 05055455503786 | Medial Rotation Knee Left Tibial Insert Size 2 18mm |
| 05055455503779 | Medial Rotation Knee Left Tibial Insert Size 2 15.5mm |
| 05055455503762 | Medial Rotation Knee Left Tibial Insert Size 2 13mm |
| 05055455503755 | Medial Rotation Knee Left Tibial Insert Size 2 10.5mm |
| 05055455503731 | Medial Rotation Knee Left Tibial Insert Size 1 18mm |
| 05055455503724 | Medial Rotation Knee Left Tibial Insert Size 1 15.5mm |
| 05055455503717 | Medial Rotation Knee Left Tibial Insert Size 1 13mm |
| 05055455503700 | Medial Rotation Knee Left Tibial Insert Size 1 10.5mm |
| 05055455503687 | Medial Rotation Knee Tibia Metal Back T5 80 Stem |
| 05055455503670 | Medial Rotation Knee Tibia Metal Back T4 80 Stem |
| 05055455503663 | Medial Rotation Knee Tibia Metal Back T3 80 Stem |
| 05055455503656 | Medial Rotation Knee Tibia Metal Back T2 80 Stem |
| 05055455503649 | Medial Rotation Knee Tibia Metal Back T1 80 Stem |
| 05055455503632 | Medial Rotation Knee Tibia Metal Back T3 50 Stem |
| 05055455503625 | Medial Rotation Knee Tibia Metal Back T2 50 Stem |
| 05055455503618 | Medial Rotation Knee Tibia Metal Back T1 50 Stem |
| 05055455503489 | Medial Rotation Knee Femoral Component Pegged Right F5 |
| 05055455503472 | Medial Rotation Knee Femoral Component Pegged Right F4 |
| 05055455503465 | Medial Rotation Knee Femoral Component Pegged Right F3 |
| 05055455503458 | Medial Rotation Knee Femoral Component Pegged Right F2 |
| 05055455503441 | Medial Rotation Knee Femoral Component Pegged Right F1 |
| 05055455503434 | Medial Rotation Knee Femoral Component Pegged Right F0 |
| 05055455503427 | Medial Rotation Knee Femoral Component Pegged Left F5 |
| 05055455503410 | Medial Rotation Knee Femoral Component Pegged Left F4 |
| 05055455503403 | Medial Rotation Knee Femoral Component Pegged Left F3 |
| 05055455503397 | Medial Rotation Knee Femoral Component Pegged Left F2 |
| 05055455503380 | Medial Rotation Knee Femoral Component Pegged Left F1 |
| 05055455503373 | Medial Rotation Knee Femoral Component Pegged Left F0 |