Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terray Corp. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063275 | DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL | Terray Corp. | 2007-07-27 | 270 | 0 |
| K003911 | TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) | Terray Corp. | 2001-03-13 | 84 | 0 |
| K003629 | MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE | Terray Corp. | 2001-02-22 | 90 | 0 |
| K974030 | CARPAL ENGAGING WRIST FUSION PLATE | Terray Corp. | 1998-01-21 | 90 | 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