| Primary Device ID | M224FRF10149 |
| NIH Device Record Key | 33c706ff-c4cd-42dc-9ae9-4c9f4778490b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2.0 mm Inion OTPS™ |
| Version Model Number | 1 |
| Catalog Number | FRF-1014 |
| Company DUNS | 367994657 |
| Company Name | Inion Oy |
| 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 |
|---|---|
| HIBCC | M224FRF10149 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-02-07 |
| M224FRF10409 | L-plate left, 7 holes |
| M224FRF10399 | L-plate right, 7 holes |
| M224FRF10389 | 6 hole plate |
| M224FRF10379 | X-plate, 7 holes |
| M224FRF10229 | 2 hole plate |
| M224FRF10169 | 10 hole plate |
| M224FRF10149 | 4 hole plate, extended |
| M224FRF10139 | 4 hole plate |
| M224PIN50029 | 2.0 mm Pins |
| M224PIN20509 | 2.0 x 50 mm pin |
| M224PIN20409 | 2.0 x 40 mm pin |
| M224PIN20359 | 2.0 x 35 mm pin |
| M224PIN20309 | 2.0 x 30 mm pin |
| M224PIN20259 | 2.0 x 25 mm pin |
| M224PIN20209 | 2.0 x 20 mm pin |
| M224PCK70029 | 2.0 mm Pin Kit |
| 06438408010323 | 2 hole plate |
| 06438408006104 | 2.0 mm Pins |
| 06438408006081 | 2.0 x 50 mm pin |
| 06438408006074 | 2.0 x 40 mm pin |
| 06438408006067 | 2.0 x 35 mm pin |
| 06438408006050 | 2.0 x 30 mm pin |
| 06438408006043 | 2.0 x 25 mm pin |
| 06438408005985 | 2.0 mm Pin Kit |
| 06438408005954 | L-plate left, 7 holes |
| 06438408005947 | L-plate right, 7 holes |
| 06438408005930 | 6 hole plate |
| 06438408005923 | X-plate, 7 holes |
| 06438408005855 | 10 hole plate |
| 06438408005848 | 4 hole plate, extended |
| 06438408005831 | 4 hole plate |
| 06438408006036 | 2.0 x 20 mm pin |
| 06438408012419 | 2.0 mm Pins |
| 06438408012402 | 2.0 mm Pin Kit |