Innobiosurg Co., Ltd.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Innobiosurg Co., Ltd.” (first 2015, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 168 days. Since 2017 the median was 134 days, against 191 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 |
|---|---|---|
| 2015 | 1 | 356 |
| 2016 | 2 | 158 |
| 2017 | 1 | 201 |
| 2018 | 1 | 168 |
| 2019 | 0 | — |
| 2020 | 6 | 60 |
| 2021 | 2 | 176 |
| 2022 | 2 | 319 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Innobiosurg Co., Ltd. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 10 | 10 |
| NHA | Abutment, Implant, Dental, Endosseous | 5 | 5 |
Review panels
- Dental (15)
Most recent Innobiosurg Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220517 | IBS System | DZE | 2022-12-20 | 300 |
| K220079 | Magicore Narrow System | DZE | 2022-12-14 | 338 |
| K212517 | Magicore System | DZE | 2021-10-15 | 66 |
| K203344 | Premilled Titanium Block System | NHA | 2021-08-25 | 285 |
| K202418 | Magic UCLA Abutment System | NHA | 2020-12-03 | 101 |
| K202479 | IBS Implant System | DZE | 2020-09-23 | 26 |
| K201981 | Magicore System | DZE | 2020-08-27 | 42 |
| K201621 | Magicore II System | NHA | 2020-07-15 | 30 |
| K200753 | IBS Implant System II | NHA | 2020-06-09 | 78 |
| K192197 | Magicore II System | DZE | 2020-04-28 | 259 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innobiosurg 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 Innobiosurg Co., Ltd.?
FDA lists 15 510(k) clearances under the applicant name “Innobiosurg Co., Ltd.” (first 2015, latest 2022), across 2 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 Innobiosurg Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innobiosurg Co., Ltd. is 168 days. Since 2017: 134 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Innobiosurg Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 10); NHA (Abutment, Implant, Dental, Endosseous, 5).
Next steps
- See all 15 Innobiosurg Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Innobiosurg 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.