Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kyung Won Medical Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100373 | TYCHE PEDICLE SCREW SYSTEM | Kyung Won Medical Co., Ltd. | 2010-06-30 | 138 | 0 |
| K092194 | POLYBONE DENTAL | Kyung Won Medical Co., Ltd. | 2010-06-16 | 330 | 0 |
| K082338 | POLYBONE GRANULE & BLOCK | Kyung Won Medical Co., Ltd. | 2008-10-16 | 63 | 0 |
| K070012 | POLYBONE | Kyung Won Medical Co., Ltd. | 2007-12-27 | 358 | 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