Innosys Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Innosys Co., Ltd.” (first 2023, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 113 days. Since 2017 the median was 113 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 |
|---|---|---|
| 2023 | 2 | 229 |
| 2024 | 3 | 56 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Innosys Co., Ltd. took a median 113 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Innosys Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241082 | INNOVERSE Navigation Instruments | OLO | 2024-06-14 | 56 |
| K234119 | UniSpace® Stand-Alone C Cage | OVE | 2024-04-19 | 113 |
| K233960 | INNOVERSE Spinal System | NKB | 2024-02-06 | 53 |
| K231737 | ANAX 5.5 Spinal System | NKB | 2023-10-26 | 134 |
| K221084 | Dyna Locking Trochanteric Nail | HSB | 2023-03-03 | 324 |
Recalls
openFDA lists no recalls under a recalling firm named Innosys Co., Ltd..
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 Innosys Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Innosys Co., Ltd.” (first 2023, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innosys Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innosys Co., Ltd. is 113 days. Since 2017: 113 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Innosys Co., Ltd.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1); OLO (Orthopedic Stereotaxic Instrument, 1).
Next steps
- See all 5 Innosys Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Innosys Co., Ltd.'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.