| Primary Device ID | 06438408000539 |
| NIH Device Record Key | 3d6ba0cc-6da4-43ea-b2ed-1fe5fc5f12e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2.0 mm Inion CPS® |
| Version Model Number | 1 |
| Catalog Number | PLT-1014 |
| Company DUNS | 367994657 |
| Company Name | Inion Oy |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 06438408000539 [Primary] |
| JEY | PLATE, BONE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-27 |
| M224SOP10339 | 90 x 90 x 0.6 mm Solid Sheet |
| M224PLT10339 | Mesh plate, 14x14 holes |
| M224PLT10329 | Mesh plate, 7x7 holes |
| 06438408011856 | 2.0 x 20 mm screw (2 x) |
| 06438408011849 | 2.0 x 17 mm screw (2 x) |
| 06438408011832 | 2.0 x 15 mm screw (2 x) |
| 06438408011825 | 2.0 x 13 mm screw (2 x) |
| 06438408011818 | 2.0 x 11 mm screw (2 x) |
| 06438408011801 | 2.0 x 9 mm screw (2 x) |
| 06438408011757 | 2.0 x 17 mm screw |
| 06438408011740 | 2.0 x 15 mm screw |
| 06438408011733 | 2.0 x 13 mm screw |
| 06438408011726 | 2.0 x 11 mm screw |
| 06438408011719 | 2.0 x 9 mm screw |
| 06438408011658 | 2.0 x 20 mm screw |
| 06438408011528 | 2.0 x 7 mm screw (5 + EMGY) |
| 06438408011511 | 2.0 x 5 mm screw (5 + EMGY) |
| 06438408011382 | Mesh plate, 14x14 holes |
| 06438408011375 | Mesh plate, 7x7 holes |
| 06438408011221 | L-plate left, 7 holes |
| 06438408011214 | L-plate right, 7 holes |
| 06438408011207 | 6 hole plate |
| 06438408011191 | X-plate, 7 holes |
| 06438408011184 | 2 hole plate |
| 06438408011177 | H-plate, 8 holes |
| 06438408011160 | C-plate, 7 holes |
| 06438408011153 | 10 hole plate |
| 06438408011146 | 4 hole plate, extended |
| 06438408011139 | 4 hole plate |
| M224SCR12899 | 2.0 x 20 mm screw (2 x) |
| M224SCR12889 | 2.0 x 17 mm screw (2 x) |
| M224SCR12879 | 2.0 x 15 mm screw (2 x) |
| M224SCR12869 | 2.0 x 13 mm screw (2 x) |
| M224SCR12859 | 2.0 x 11 mm screw (2 x) |
| M224SCR12849 | 2.0 x 9 mm screw (2 x) |
| M224SCR12839 | 2.0 x 17 mm screw |
| M224SCR12829 | 2.0 x 15 mm screw |
| M224SCR12819 | 2.0 x 13 mm screw |
| M224SCR12809 | 2.0 x 11 mm screw |
| M224SCR12799 | 2.0 x 9 mm screw |
| M224SCR12339 | 2.0 x 20 mm screw |
| M224SCR12259 | 2.0 x 7 mm screw (5 + EMGY) |
| M224SCR12249 | 2.0 x 5 mm screw (5 + EMGY) |
| M224PLT10409 | L-plate left, 7 holes |
| M224PLT10399 | L-plate right, 7 holes |
| M224PLT10389 | 6 hole plate |
| M224PLT10379 | X-plate, 7 holes |
| M224PLT10229 | 2 hole plate |
| M224PLT10209 | H-plate, 8 holes |
| M224PLT10179 | C-plate, 7 holes |