Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paonan Biotech Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
364 daysmedian FDA review time
452 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220261 | NEST-C Interbody System | Paonan Biotech Co., Ltd. | 2023-04-24 | 448 | 0 |
| K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | 2019-06-20 | 301 | 0 |
| K180230 | NEST Interbody System | Paonan Biotech Co., Ltd. | 2019-01-25 | 364 | 0 |
| K180228 | II-Type Intervertebral Spacer | Paonan Biotech Co., Ltd. | 2019-01-11 | 350 | 0 |
| K180226 | TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. | 2018-07-25 | 180 | 0 |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. | 2017-08-11 | 452 | 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