Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Frontier Medical Devices, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
412 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage S | Frontier Medical Devices, Inc. | 2016-01-13 | 65 | 0 |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage S | Frontier Medical Devices, Inc. | 2015-10-30 | 112 | 0 |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Frontier Medical Devices, Inc. | 2015-08-20 | 92 | 0 |
| K143228 | Ancora LLC Interbody Fusion Device | Frontier Medical Devices, Inc. | 2015-02-26 | 108 | 0 |
| K112700 | FRONTIER SADL INTERBODY FUSION DEVICE | Frontier Medical Devices, Inc. | 2012-11-01 | 412 | 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