Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immedica, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
90 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023575 | CONCERT CRANIOPLAST | Immedica, Inc. | 2003-01-22 | 90 | 0 |
| K013755 | CONCERT RADIOPAQUE BONE CEMENT | Immedica, Inc. | 2002-02-08 | 87 | 0 |
| K003205 | TRANSFX ANGLED RODS | Immedica, Inc. | 2000-12-15 | 63 | 7 |
| K001228 | EXTERNAL FIXATION ANCHOR PIN | Immedica, Inc. | 2000-07-07 | 81 | 0 |
| K001084 | TRANS FX ADJUSTABLE PIN TO BAR CLAMP | Immedica, Inc. | 2000-06-15 | 72 | 0 |
| K991723 | TRANSFX MULTI PIN CLAMP | Immedica, Inc. | 1999-07-22 | 63 | 7 |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL | Immedica, Inc. | 1999-05-17 | 63 | 8 |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM | Immedica, Inc. | 1999-03-04 | 87 | 7 |
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