Spine Wave, Inc.
FDA 510(k) & PMA Approved Devices — 22 products
Total Devices22
Categories7
Latest Approval2025-06-27
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K243816 | Testa TP Pivoting Spacer System | MAX | 2025-06-27 | View |
| 510(k) | K251131 | Annex® 2 Adjacent Level System | NKB | 2025-06-06 | View |
| 510(k) | K243514 | Salvo® Robotic Navigation Instruments | OLO | 2025-04-03 | View |
| 510(k) | K240685 | Salvo® Spine System | NKB | 2024-05-06 | View |
| 510(k) | K231275 | Exceed Biplanar Expandable Interbody System | MAX | 2023-07-25 | View |
| 510(k) | K222362 | Salvo® Spine System | NKB | 2022-08-29 | View |
| 510(k) | K202476 | Salvo® Spine System | NKB | 2020-11-05 | View |
| 510(k) | K192526 | Spine Wave Navigated Instruments | OLO | 2019-10-10 | View |
| 510(k) | K191045 | Salvo Spine System | NKB | 2019-07-10 | View |
| 510(k) | K182954 | Salvo Spine System | NKB | 2018-12-12 | View |
| 510(k) | K181596 | Spine Wave Navigated Instruments | OLO | 2018-10-24 | View |
| 510(k) | K181440 | Proficient® Posterior Cervical Spine System | NKG | 2018-07-30 | View |
| 510(k) | K172594 | Proficient® Posterior Cervical Spine System | NKG | 2017-12-15 | View |
| 510(k) | K173175 | Paramount Anterior Cervical Cage System | OVE | 2017-11-01 | View |
| 510(k) | K172175 | CapSure® PS System | NKB | 2017-08-16 | View |
| 510(k) | K163246 | Leva Anterior Expandable Spacer System | MAX | 2017-04-06 | View |
| 510(k) | K162760 | Spine Wave Anterior Cervical Spine System | OVE | 2017-02-16 | View |
| 510(k) | K162639 | Proficient Posterior Cervical Spine System | NKG | 2017-02-07 | View |
| 510(k) | K161993 | Leva® Anterior Interbody System | OVD | 2016-11-22 | View |
| 510(k) | K153222 | Leva Spacer System | MAX | 2016-04-15 | View |
| 510(k) | K160003 | Sniper (R) Spine System | MNI | 2016-02-26 | View |
| 510(k) | K152620 | Spine Wave Gen II Expandable Interbody System | MAX | 2016-01-15 | View |
No matching devices.