Innovasis, Inc.
FDA 510(k) & PMA Approved Devices — 20 products
Total Devices20
Categories9
Latest Approval2025-07-23
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | OLO | 2025-07-23 | View |
| 510(k) | K250182 | Innovasis Navigation Instruments | OLO | 2025-03-24 | View |
| 510(k) | K241276 | Vector Pedicle Screw System | NKB | 2024-05-20 | View |
| 510(k) | K231899 | HAtetracell-C Titanium Cervical IBF System | ODP | 2023-10-17 | View |
| 510(k) | K223511 | Excella Navigation Instruments | OLO | 2023-05-02 | View |
| 510(k) | K223510 | Matrix HA Fusion Porous Cervical IBF System | ODP | 2022-12-12 | View |
| 510(k) | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | ODP | 2022-08-26 | View |
| 510(k) | K212967 | AxTiHA Stand-Alone ALIF System | OVD | 2021-10-15 | View |
| 510(k) | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | MAX | 2020-07-15 | View |
| 510(k) | K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | FST | 2020-06-30 | View |
| 510(k) | K192049 | Oryx Cervical Plate System | KWQ | 2019-11-08 | View |
| 510(k) | K192354 | Innovasis Gibralt Spine System | NKG | 2019-09-24 | View |
| 510(k) | K183064 | TxTi IBF System | MAX | 2019-06-28 | View |
| 510(k) | K182139 | AXTi Titanium Stand-Alone ALIF System | OVD | 2019-06-21 | View |
| 510(k) | K190684 | LxHA PEEK Lateral IBF System | MAX | 2019-06-17 | View |
| 510(k) | K181115 | CxHA PEEK Cervical IBF System | ODP | 2018-07-16 | View |
| 510(k) | K181063 | Kestrel Buttress Plate System | KWQ | 2018-07-13 | View |
| 510(k) | K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | MAX | 2018-04-17 | View |
| 510(k) | K162236 | Ax Stand-Alone ALIF System | OVD | 2017-04-20 | View |
| 510(k) | K162143 | FixxSure® X-Link | MNH | 2016-09-23 | View |
No matching devices.