Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomaterials Korea, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
251 daysmedian FDA review time
391 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222245 | ACR Screw System | Biomaterials Korea, Inc. | 2023-08-21 | 391 | 0 |
| K173623 | Anchor plate | Biomaterials Korea, Inc. | 2018-08-30 | 279 | 0 |
| K110926 | BONE PLATE; BONE SCREW | Biomaterials Korea, Inc. | 2011-12-08 | 251 | 0 |
| K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCH | Biomaterials Korea, Inc. | 2011-09-26 | 91 | 0 |
| K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | Biomaterials Korea, Inc. | 2007-07-26 | 248 | 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