Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Phygen, LLC · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
145 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120355 | LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM | Phygen, LLC | 2012-03-07 | 30 | 0 |
| K113366 | LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM | Phygen, LLC | 2012-01-17 | 63 | 1 |
| K112931 | LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM | Phygen, LLC | 2011-11-02 | 30 | 0 |
| K110679 | DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM | Phygen, LLC | 2011-08-02 | 145 | 0 |
| K110588 | LEUCADIA PEDICLE SCREW SYSTEM | Phygen, LLC | 2011-05-25 | 84 | 0 |
| K103748 | LAGUNA PEDICLE SCREW SYSTEM | Phygen, LLC | 2011-03-02 | 69 | 0 |
| K103102 | LEUCADIA PEDICLE SCREW SYSTEM | Phygen, LLC | 2011-02-08 | 111 | 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