Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K131609
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM · Xiamen Double Engine Medical Material Co., Ltd. · decided 2014-05-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 5.0mm Dual Core Locking Screw | 071260050 | Double Medical Technology Inc. | HSB | 06942782417277 |
| Universal Tibial Nail, Solid | 070050300 | Double Medical Technology Inc. | HSB | 06942782413408 |
| Universal Tibial Nail, Cannulated | 070030255 | Double Medical Technology Inc. | HSB | 06942782485504 |
| 4.9mm Locking Screw for DFN II/UFN II/UTN II | 071210074 | Double Medical Technology Inc. | HSB | 06942782416959 |
| Universal Tibial Nail, Cannulated | 070020255 | Double Medical Technology Inc. | HSB | 06942782416119 |
| Drill Sleeve for Drill Bits, φ8.1/φ4.2 | 111224600 | Double Medical Technology Inc. | HSB | 06902139112224 |
| Guide Wire, with olive head, φ2.5, length 1000mm | 111191000 | Double Medical Technology Inc. | HSB | 06902139111999 |
| Universal Tibial Nail, Solid | 070060360 | Double Medical Technology Inc. | HSB | 06902139071538 |
| Universal Tibial Nail II, Cannulated | 071170330 | Double Medical Technology Inc. | HSB | 06942782417635 |
| 4.9mm Locking Screw for DFN II/UFN II/UTN II | 071210060 | Double Medical Technology Inc. | HSB | 06942782416881 |
| 4.0mm Locking Screw | 071250028 | Double Medical Technology Inc. | HSB | 06942782416485 |
| Universal Tibial Nail, Solid | 070040300 | Double Medical Technology Inc. | HSB | 06942782413354 |
| Trocar Φ8.0 | 110302100 | Double Medical Technology Inc. | HSB | 06902139111623 |
| Inserter-Extractor for Tibial Nail | 110301600 | Double Medical Technology Inc. | HSB | 06902139111579 |
| 4.0mm Locking Screw | 071250038 | Double Medical Technology Inc. | HSB | 06942782416539 |
| Connecting Screw, for insertion handle | 111222700 | Double Medical Technology Inc. | HSB | 06902139112132 |
| Universal Tibial Nail II, Cannulated | 071160285 | Double Medical Technology Inc. | HSB | 06942782417529 |
| 4.0mm Locking Screw | 071250066 | Double Medical Technology Inc. | HSB | 06942782417222 |
| Tissue Protector | 111220600 | Double Medical Technology Inc. | HSB | 06902139112088 |
| 4.9mm Locking Screw for DFN II/UFN II/UTN II | 071210046 | Double Medical Technology Inc. | HSB | 06942782417185 |
| 4.5mm Locking Screw for Tibial Nail | 070070055 | Double Medical Technology Inc. | HSB | 06942782413910 |
| U-Clip Φ9.0 | 110301400 | Double Medical Technology Inc. | HSB | 06902139111555 |
| Drill Bit, φ5 | 110355400 | Double Medical Technology Inc. | HSB | 06902139111913 |
| Drill Sleeve for Calibrating Pin, φ5.0 | 110355600 | Double Medical Technology Inc. | HSB | 06902139111937 |
| Universal Tibial Nail II, Cannulated | 071160315 | Double Medical Technology Inc. | HSB | 06942782417543 |