| Primary Device ID | 08800048401447 |
| NIH Device Record Key | 205014ee-e674-420c-9b19-d52a4323cef5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Iliad Spinal System |
| Version Model Number | PO4020 |
| Company DUNS | 688211503 |
| Company Name | Medyssey Co., 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800048401447 [Primary] |
| MNI | Orthosis, spinal pedicle fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
[08800048401447]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-14 |
| Device Publish Date | 2023-02-06 |
| 08800048446806 | Polyaxial Pedicle Screw, Ø8.0mm X 40mm, Ø6.35mm (1/4-inch) Rod |
| 08800048446790 | Polyaxial Pedicle Screw, Ø7.5mm X 95mm, Ø6.35mm (1/4-inch) Rod |
| 08800048446783 | Polyaxial Pedicle Screw, Ø7.5mm X 85mm, Ø6.35mm (1/4-inch) Rod |
| 08800048446776 | Polyaxial Pedicle Screw, Ø7.5mm X 75mm, Ø6.35mm (1/4-inch) Rod |
| 08800048401621 | Polyaxial Pedicle Screw, Ø5.0mm X 45mm , Ø6.0mm Rod |
| 08800048401614 | Polyaxial Pedicle Screw, Ø5.0mm X 40mm , Ø6.0mm Rod |
| 08800048401607 | Polyaxial Pedicle Screw, Ø5.0mm X 35mm , Ø6.0mm Rod |
| 08800048401591 | Polyaxial Pedicle Screw, Ø5.0mm X 30mm , Ø6.0mm Rod |
| 08800048401584 | Polyaxial Pedicle Screw, Ø5.0mm X 25mm , Ø6.0mm Rod |
| 08800048401577 | Polyaxial Pedicle Screw, Ø5.0mm X 20mm , Ø6.0mm Rod |
| 08800048401546 | Polyaxial Pedicle Screw, Ø4.5mm X 45mm , Ø6.0mm Rod |
| 08800048401539 | Polyaxial Pedicle Screw, Ø4.5mm X 40mm , Ø6.0mm Rod |
| 08800048401522 | Polyaxial Pedicle Screw, Ø4.5mm X 35mm , Ø6.0mm Rod |
| 08800048401515 | Polyaxial Pedicle Screw, Ø4.5mm X 30mm , Ø6.0mm Rod |
| 08800048401508 | Polyaxial Pedicle Screw, Ø4.5mm X 25mm , Ø6.0mm Rod |
| 08800048401492 | Polyaxial Pedicle Screw, Ø4.5mm X 20mm , Ø6.0mm Rod |
| 08800048401485 | Polyaxial Pedicle Screw, Ø4.0mm X 40mm , Ø6.0mm Rod |
| 08800048401478 | Polyaxial Pedicle Screw, Ø4.0mm X 35mm , Ø6.0mm Rod |
| 08800048401461 | Polyaxial Pedicle Screw, Ø4.0mm X 30mm , Ø6.0mm Rod |
| 08800048401454 | Polyaxial Pedicle Screw, Ø4.0mm X 25mm , Ø6.0mm Rod |
| 08800048401447 | Polyaxial Pedicle Screw, Ø4.0mm X 20mm , Ø6.0mm Rod |
| 08806364651269 | Cannulated Poly-Axial Screw 8.5mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651252 | Cannulated Poly-Axial Screw 8.5mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651245 | Cannulated Poly-Axial Screw 8.5mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651238 | Cannulated Poly-Axial Screw 8.5mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651221 | Cannulated Poly-Axial Screw 8.5mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651214 | Cannulated Poly-Axial Screw 8.5mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651207 | Cannulated Poly-Axial Screw 8.5mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651191 | Cannulated Poly-Axial Screw 8.0mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651184 | Cannulated Poly-Axial Screw 8.0mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651177 | Cannulated Poly-Axial Screw 8.0mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651160 | Cannulated Poly-Axial Screw 8.0mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651153 | Cannulated Poly-Axial Screw 8.0mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651146 | Cannulated Poly-Axial Screw 8.0mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651139 | Cannulated Poly-Axial Screw 8.0mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651122 | Cannulated Poly-Axial Screw 7.5mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651115 | Cannulated Poly-Axial Screw 7.5mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651108 | Cannulated Poly-Axial Screw 7.5mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651092 | Cannulated Poly-Axial Screw 7.5mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651085 | Cannulated Poly-Axial Screw 7.5mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651078 | Cannulated Poly-Axial Screw 7.5mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651061 | Cannulated Poly-Axial Screw 7.5mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651054 | Cannulated Poly-Axial Screw 7.0mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651047 | Cannulated Poly-Axial Screw 7.0mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651030 | Cannulated Poly-Axial Screw 7.0mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651023 | Cannulated Poly-Axial Screw 7.0mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651016 | Cannulated Poly-Axial Screw 7.0mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364651009 | Cannulated Poly-Axial Screw 7.0mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364650996 | Cannulated Poly-Axial Screw 7.0mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type |
| 08806364606504 | Reduction Monoaxial Pedicle Screw, Ø8.5mm X 60mm, Ø6.35mm (1/4-inch) Rod |