Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innovasis, Inc. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
235 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Inst | Innovasis, Inc. | 2025-07-23 | 106 | 1 |
| K250182 | Innovasis Navigation Instruments | Innovasis, Inc. | 2025-03-24 | 61 | 1 |
| K241276 | Vector™ Pedicle Screw System | Innovasis, Inc. | 2024-05-20 | 14 | 1 |
| K231899 | HAtetracell™-C Titanium Cervical IBF System | Innovasis, Inc. | 2023-10-17 | 111 | 0 |
| K223511 | Excella Navigation Instruments | Innovasis, Inc. | 2023-05-02 | 161 | 0 |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | Innovasis, Inc. | 2022-12-12 | 20 | 0 |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | 2022-08-26 | 154 | 0 |
| K212967 | AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2021-10-15 | 29 | 0 |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020-07-15 | 30 | 1 |
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, | Innovasis, Inc. | 2020-06-30 | 90 | 0 |
| K192049 | Oryx Cervical Plate System | Innovasis, Inc. | 2019-11-08 | 100 | 0 |
| K192354 | Innovasis Gibralt Spine System | Innovasis, Inc. | 2019-09-24 | 26 | 0 |
| K183064 | TxTi IBF System | Innovasis, Inc. | 2019-06-28 | 235 | 1 |
| K182139 | AXTi Titanium Stand-Alone ALIF System | Innovasis, Inc. | 2019-06-21 | 318 | 0 |
| K190684 | LxHA PEEK Lateral IBF System | Innovasis, Inc. | 2019-06-17 | 91 | 0 |
| K181115 | CxHA PEEK Cervical IBF System | Innovasis, Inc. | 2018-07-16 | 80 | 0 |
| K181063 | Kestrel™ Buttress Plate System | Innovasis, Inc. | 2018-07-13 | 81 | 0 |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF Sys | Innovasis, Inc. | 2018-04-17 | 97 | 1 |
| K162236 | Ax Stand-Alone ALIF System | Innovasis, Inc. | 2017-04-20 | 254 | 0 |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 | 53 | 0 |
| K151785 | Px HA PEEK IBF System | Innovasis, Inc. | 2015-10-14 | 105 | 0 |
| K150500 | Px PEEK IBF System | Innovasis, Inc. | 2015-06-19 | 113 | 0 |
| K141644 | INNOVASIS CRANIAL SYSTEM | Innovasis, Inc. | 2014-11-07 | 141 | 0 |
| K132765 | PFX SPINOUS PROCESS FIXATION SYSTEM | Innovasis, Inc. | 2014-07-14 | 313 | 0 |
| K140238 | EXCELLA III-D SPINAL DEFORMITY SYSTEM | Innovasis, Inc. | 2014-05-07 | 97 | 2 |
| K132991 | C-BOX PEEK CERVICAL IBF | Innovasis, Inc. | 2014-02-12 | 141 | 0 |
| K121581 | BOX PEEK VBR SYSTEM, | Innovasis, Inc. | 2012-10-17 | 140 | 0 |
| K102248 | EXCELLA II SPINAL SYSTEM MODEL EC2-00 | Innovasis, Inc. | 2010-10-07 | 59 | 2 |
| K071921 | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS | Innovasis, Inc. | 2007-11-16 | 127 | 0 |
| K062151 | BOX PEEK VBR SYSTEM | Innovasis, Inc. | 2006-12-22 | 148 | 0 |
| K061147 | OPTERYX ANTERIOR CERVICAL PLATE SYSTEM | Innovasis, Inc. | 2006-06-30 | 66 | 1 |
| K042143 | EXCELLA-M SPINAL SYSTEM | Innovasis, Inc. | 2004-10-07 | 59 | 0 |
| K041583 | PEEK CEMENT RESTRICTOR X-BOX | Innovasis, Inc. | 2004-07-22 | 41 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda