Paonan Biotech Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Paonan Biotech Co., Ltd.” (first 2017, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 357 days. Since 2017 the median was 357 days, against 91 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 |
|---|---|---|
| 2017 | 1 | 452 |
| 2018 | 1 | 180 |
| 2019 | 3 | 350 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 448 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paonan Biotech Co., Ltd. took a median 357 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Paonan Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220261 | NEST-C Interbody System | ODP | 2023-04-24 | 448 |
| K182285 | PK High Tibial Osteotomy Correction System | KTW | 2019-06-20 | 301 |
| K180230 | NEST Interbody System | MAX | 2019-01-25 | 364 |
| K180228 | II-Type Intervertebral Spacer | MAX | 2019-01-11 | 350 |
| K180226 | TREND II Spinal Fixation System- STEP Series | NKB | 2018-07-25 | 180 |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | NKB | 2017-08-11 | 452 |
Recalls
openFDA lists no recalls under a recalling firm named Paonan Biotech 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 Paonan Biotech Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Paonan Biotech Co., Ltd.” (first 2017, latest 2023), 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 Paonan Biotech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paonan Biotech Co., Ltd. is 357 days. Since 2017: 357 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Paonan Biotech Co., Ltd.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); NKB (Thoracolumbosacral Pedicle Screw System, 2); KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, 1).
Next steps
- See all 6 Paonan Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Paonan Biotech 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.