Innovasis, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Innovasis, Inc.” (first 2004, latest 2025), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 97 days. Since 2017 the median was 91 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 140 |
| 2013 | 0 | — |
| 2014 | 4 | 141 |
| 2015 | 2 | 109 |
| 2016 | 1 | 53 |
| 2017 | 1 | 254 |
| 2018 | 3 | 81 |
| 2019 | 5 | 100 |
| 2020 | 2 | 60 |
| 2021 | 1 | 29 |
| 2022 | 2 | 87 |
| 2023 | 2 | 136 |
| 2024 | 1 | 14 |
| 2025 | 4 | 84 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Innovasis, Inc. took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 7 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 5 | 5 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| FST | Light, Surgical, Fiberoptic | 1 | 1 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Plus 5 more product codes.
Review panels
- Orthopedic (33)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Innovasis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250076 | Endeavor Stand-Alone Cervical IBF System | OVE | 2025-09-25 | 258 |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | OLO | 2025-07-23 | 106 |
| K250603 | AxTiHA® Stand-Alone ALIF System | OVD | 2025-03-24 | 24 |
| K250182 | Innovasis Navigation Instruments | OLO | 2025-03-24 | 61 |
| K241276 | Vector Pedicle Screw System | NKB | 2024-05-20 | 14 |
| K231899 | HAtetracell-C Titanium Cervical IBF System | ODP | 2023-10-17 | 111 |
| K223511 | Excella Navigation Instruments | OLO | 2023-05-02 | 161 |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | ODP | 2022-12-12 | 20 |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | ODP | 2022-08-26 | 154 |
| K212967 | AxTiHA Stand-Alone ALIF System | OVD | 2021-10-15 | 29 |
25 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2026-05-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovasis, Inc.?
FDA lists 35 510(k) clearances under the applicant name “Innovasis, Inc.” (first 2004, latest 2025), across 15 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innovasis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovasis, Inc. is 97 days. Since 2017: 91 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Innovasis, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 5); NKB (Thoracolumbosacral Pedicle Screw System, 4).
Next steps
- See all 35 Innovasis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Innovasis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.