Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K190885
Elevation Spine Saber-C System · Elevation Spine · decided 2019-08-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Trial Head 15x18x9 12 deg. | CI-TH5829 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017915095 |
| 14(w) x 15(d) Saber-C Bodies (Titanium) | CBT-4505 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017911028 |
| Trial Head 15x18x8 12 deg. | CI-TH5828 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017915088 |
| Trial Handle | CI-HANDLE-T | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912339 |
| Drill, Straight | CI-DRILLS | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912292 |
| 15 (w) X 18 (d) Saber-C Cervical Plate | CP-5805 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912100 |
| 14 (w) X 17 (d) Saber-C Cervical Plate | CP-4768 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912018 |
| 14 (w) X 17 (d) Saber-C Cervical Plate | CP-4795 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912049 |
| 14 (w) X 17 (d) Saber-C Cervical Plate | CP-4708 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017911950 |
| 14(w) x 15(d) Saber-C Bodies (Titanium) | CBT-4597 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017911165 |
| 14(w) x 15(d) Saber-C Bodies (Titanium) | CBT-4595 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017911141 |
| Trial Head 12x15x7 12 deg. | CI-TH2527 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017914906 |
| 12(w) x 15(d) Saber-C Bodies (Titanium) | CBT-2561 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017910953 |
| 15 (w) X 18 (d) Saber-C Bodies (PEEK) | CBP-5861 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017910779 |
| Trial Head 14x15x10 12 deg. | CI-TH4521 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017915002 |
| Trial Head 14x17x9 9 deg. | CI-TH4799 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912841 |
| Trial Head 12x15x6 9 deg. | CI-TH2596 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912636 |
| Guide, 9mm | CI-GUIDE-09 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912438 |
| Double Ended Rasp/Trial 14x17x8, 6° | 522-81011 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017914852 |
| 14 (w) X 17 (d) Saber-C Cervical Plate | CP-4705 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017911929 |
| 14 (w) X 17 (d) Saber-C Bodies (PEEK) | CBP-4795 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017910601 |
| Ø3.3 Screw xxmm long implants | CS-14 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017910014 |
| Angled Driver | CI-ANG-DRIVER | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017914159 |
| 12 (w) X 15 (d) Saber-C Cervical Plate | CP-2598 | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017911714 |
| Spike Driver (Final) | CI-DRIVER-SPF | ELEVATION SPINE, INC. | KWQ ODP OVE | 00810017912391 |