Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gm Dos Reis Industria E Comerico Ltda. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchor | Gm Dos Reis Industria E Comerico Ltda. | 2023-08-02 | 303 | 0 |
| K182718 | Mini and Micro Fragments Reconstruction System – GMReis | Gm Dos Reis Industria E Comerico Ltda. | 2019-12-23 | 451 | 0 |
| K180626 | Pedimax II - Pedicular Screw Spinal System | Gm Dos Reis Industria E Comerico Ltda. | 2019-02-01 | 329 | 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