Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180377
Fracture and Correction System · In2bones USA, LLC · decided 2018-06-20 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CoLag 2 | P67 ST440 | In2Bones USA, LLC | HWC | 00817906025736 |
| Fracture and Correction CoLag™ 2 | P67 ST885 | In2Bones USA, LLC | HWC | 00817906024920 |
| CoLag 2 | P67 ST445 | In2Bones USA, LLC | HWC | 00817906025750 |
| CoLag 2 | P67 ST237 | In2Bones USA, LLC | HWC | 00817906025408 |
| Fracture and Correction CoLag™ 2 | P67 ST640 | In2Bones USA, LLC | HWC | 00817906024432 |
| Fracture and Correction CoLag™ 2 | P67 ST675 | In2Bones USA, LLC | HWC | 00817906024579 |
| CoLag 2 | P67 ST426 | In2Bones USA, LLC | HWC | 00817906025668 |
| Fracture and Correction CoLag™ 2 | P67 ST830 | In2Bones USA, LLC | HWC | 00817906024692 |
| Fracture and Correction CoLag™ | P65 ST112 | In2Bones USA, LLC | HWC | 00817906022780 |
| Fracture and Correction CoLag™ | P65 ST114 | In2Bones USA, LLC | HWC | 00817906022803 |
| Fracture and Correction CoLag™2 | P67 ST538 | In2Bones USA, LLC | HWC | 00817906025866 |
| CoLag 2 | P67 ST242 | In2Bones USA, LLC | HWC | 00817906025422 |
| CoLag 2 | P67 ST232 | In2Bones USA, LLC | HWC | 00817906025385 |
| Fracture and Correction CoLag™ 2 | P67 ST910 | In2Bones USA, LLC | HWC | 00817906024982 |
| CoLag 2 | P68 ST122 | In2Bones USA, LLC | HWC | 00817906029000 |
| Fracture and Correction CoLag™ 2 | P67 ST880 | In2Bones USA, LLC | HWC | 00817906024906 |
| Fracture and Correction CoLag™ 2 | P68 ST257 | In2Bones USA, LLC | HWC | 00817906029307 |
| CoLag 2 | P68 ST134 | In2Bones USA, LLC | HWC | 00817906029062 |
| Fracture and Correction CoLag™2 | P67 ST532 | In2Bones USA, LLC | HWC | 00817906025835 |
| CoLag 2 | P67 ST230 | In2Bones USA, LLC | HWC | 00817906025378 |
| Fracture and Correction CoLag™ 2 | P67 ST875 | In2Bones USA, LLC | HWC | 00817906024883 |
| CoLag 2 | P67 ST255 | In2Bones USA, LLC | HWC | 00817906025477 |
| Fracture and Correction CoLag™ 2 | P67 ST840 | In2Bones USA, LLC | HWC | 00817906024746 |
| CoLag 2 | P68 ST155 | In2Bones USA, LLC | HWC | 00817906029154 |
| CoLag 2 | P67 ST226 | In2Bones USA, LLC | HWC | 00817906025354 |