Innovasis, Inc
FDA Regulatory Profile
Innovasis, Inc appears in FDA public data with 6 recalls, 35 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3163-2024, Class II) was initiated on August 14, 2024. Its most recent 510(k) clearance was granted on September 25, 2025.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 35
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3163-2024 | Class II | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an in | August 14, 2024 |
| Z-2062-2020 | Class II | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product | April 7, 2020 |
| Z-0644-2018 | Class II | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is | January 8, 2018 |
| Z-2153-2017 | Class II | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-seal | May 5, 2017 |
| Z-0662-2016 | Class II | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 | December 7, 2015 |
| Z-2067-2014 | Class II | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fi | July 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250076 | Endeavor Stand-Alone Cervical IBF System | September 25, 2025 |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation I | July 23, 2025 |
| K250603 | AxTiHA® Stand-Alone ALIF System | March 24, 2025 |
| K250182 | Innovasis Navigation Instruments | March 24, 2025 |
| K241276 | Vector Pedicle Screw System | May 20, 2024 |
| K231899 | HAtetracell-C Titanium Cervical IBF System | October 17, 2023 |
| K223511 | Excella Navigation Instruments | May 2, 2023 |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | December 12, 2022 |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | August 26, 2022 |
| K212967 | AxTiHA Stand-Alone ALIF System | October 15, 2021 |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | July 15, 2020 |
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal En | June 30, 2020 |
| K192049 | Oryx Cervical Plate System | November 8, 2019 |
| K192354 | Innovasis Gibralt Spine System | September 24, 2019 |
| K183064 | TxTi IBF System | June 28, 2019 |
| K182139 | AXTi Titanium Stand-Alone ALIF System | June 21, 2019 |
| K190684 | LxHA PEEK Lateral IBF System | June 17, 2019 |
| K181115 | CxHA PEEK Cervical IBF System | July 16, 2018 |
| K181063 | Kestrel Buttress Plate System | July 13, 2018 |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | April 17, 2018 |