Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201253
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation · Smith & Nephew · decided 2020-12-08 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ILIZAROV | 71111500 | Smith & Nephew, Inc. | JDW | 00885556014691 |
| OTHER EXTERNAL FIXATION | 103452 | Smith & Nephew, Inc. | JDW | 03596010512765 |
| No Brand | 122720 | Smith & Nephew, Inc. | KTT | 03596010069542 |
| Jet-X | 71065304S | Smith & Nephew, Inc. | JDW | 00885556013014 |
| Jet-X | 71056609 | Smith & Nephew, Inc. | JDW | 00885556011416 |
| (unnamed) | 290058 | Smith & Nephew, Inc. | KTT | 23596010113348 |
| OTHER EXTERNAL FIXATION | 103453 | Smith & Nephew, Inc. | JDW | 03596010512772 |
| ILIZAROV | 102412 | Smith & Nephew, Inc. | JDW | 03596010031600 |
| Jet-X | 71066459S | Smith & Nephew, Inc. | JDW | 00885556012789 |
| ILIZAROV | 201030 | Smith & Nephew, Inc. | JDW | 03596010100856 |
| Jet-X | 71064308S | Smith & Nephew, Inc. | JDW | 00885556012956 |
| Jet-X | 71065708S | Smith & Nephew, Inc. | JDW | 00885556013298 |
| (unnamed) | 122771 | Smith & Nephew, Inc. | LXT | 03596010069887 |
| (unnamed) | 122755 | Smith & Nephew, Inc. | LXT | 03596010069788 |
| OTHER EXFIX | 122735 | Smith & Nephew, Inc. | KTT | 03596010069610 |
| Jet-X | 71063208S | Smith & Nephew, Inc. | JDW | 00885556012567 |
| Jet-X | 71065408S | Smith & Nephew, Inc. | JDW | 00885556012246 |
| (unnamed) | 71021023 | Smith & Nephew, Inc. | LXT | 03596010170903 |
| HEX-FIX | 122750 | Smith & Nephew, Inc. | LXT | 03596010512796 |
| (unnamed) | 71021025 | Smith & Nephew, Inc. | LXT | 03596010170927 |
| HEX-FIX | 122749 | Smith & Nephew, Inc. | LXT | 03596010512789 |
| (unnamed) | 122760 | Smith & Nephew, Inc. | LXT | 03596010069832 |
| OTHER EXTERNAL FIXATION | 112734 | Smith & Nephew, Inc. | LXT | 03596010042460 |
| HEX-FIX | 122725 | Smith & Nephew, Inc. | KTT | 03596010069566 |
| ILIZAROV | 71102107 | Smith & Nephew, Inc. | JDW | 00885556013625 |