Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osteomed, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
192 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212570 | OsteoPlan System | Osteomed, LLC | 2022-02-11 | 179 | 0 |
| K202105 | OsteoMed ExtremiFix Mini & Small System Tray | Osteomed, LLC | 2020-10-29 | 92 | 0 |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System | Osteomed, LLC | 2020-10-15 | 30 | 0 |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC | 2018-05-10 | 192 | 0 |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw System | Osteomed, LLC | 2017-04-04 | 133 | 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