Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K170318
NeoFuse Ti3D PLIF/TLIF/Cervical Interbody · Ht Medical, LLC · decided 2017-07-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Ti3D CERVICAL | C1412-07 | XENIX MEDICAL LLC | ODP | 00818345020856 |
| NeoFuse Ti3D PLIF/TLIF | C2410-14 | XENIX MEDICAL LLC | ODP | 00818345021181 |
| Ti3D CERVICAL | C1412-05 | XENIX MEDICAL LLC | ODP | 00818345020832 |
| Ti3D CERVICAL | C1614-05 | XENIX MEDICAL LLC | ODP | 00818345020917 |
| Ti3D CERVICAL | B242-12 | XENIX MEDICAL LLC | ODP | 00818345023666 |
| Ti3D CERVICAL | B242-05 | XENIX MEDICAL LLC | ODP | 00818345023598 |
| Ti3D CERVICAL | C1613-09 | XENIX MEDICAL LLC | ODP | 00818345023208 |
| NeoFuse Ti3D PLIF/TLIF | C3012-13 | XENIX MEDICAL LLC | MAX | 00818345021778 |
| NeoFuse Ti3D PLIF/TLIF | C3010-09 | XENIX MEDICAL LLC | MAX | 00818345021259 |
| Ti3D CERVICAL | C1412-10 | XENIX MEDICAL LLC | ODP | 00818345020887 |
| Ti3D CERVICAL | B242-08 | XENIX MEDICAL LLC | ODP | 00818345023628 |
| NeoFuse Ti3D PLIF/TLIF | C2012-12 | XENIX MEDICAL LLC | MAX | 00818345021525 |
| NeoFuse Ti3D PLIF/TLIF | C3210-13 | XENIX MEDICAL LLC | MAX | 00818345021419 |
| NeoFuse Ti3D PLIF/TLIF | C2010-11 | XENIX MEDICAL LLC | MAX | 00818345021037 |
| Ti3D CERVICAL | B221-10 | XENIX MEDICAL LLC | ODP | 00818345023567 |
| NeoFuse Ti3D PLIF/TLIF | C2412-11 | XENIX MEDICAL LLC | MAX | 00818345021631 |
| Ti3D CERVICAL | C1211-11 | XENIX MEDICAL LLC | ODP | 00818345020818 |
| Ti3D CERVICAL | B24-05 | XENIX MEDICAL LLC | LXH | 00818345023352 |
| NeoFuse Ti3D PLIF/TLIF | C2012-17 | XENIX MEDICAL LLC | MAX | 00818345021570 |
| NeoFuse Ti3D PLIF/TLIF | C3012-14 | XENIX MEDICAL LLC | MAX | 00818345021785 |
| NeoFuse Ti3D PLIF/TLIF | C2012-09 | XENIX MEDICAL LLC | MAX | 00818345021495 |
| Ti3D CERVICAL | B263-11 | XENIX MEDICAL LLC | ODP | 00818345023734 |
| Ti3D CERVICAL | B263-05 | XENIX MEDICAL LLC | ODP | 00818345023673 |
| NeoFuse Ti3D PLIF/TLIF | C3212-17 | XENIX MEDICAL LLC | MAX | 00818345021938 |
| NeoFuse Ti3D PLIF/TLIF | C2410-17 | XENIX MEDICAL LLC | MAX | 00818345021211 |