Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GM Dos Reis Industria e Comercio Ltda. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
262 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 | 83 | 0 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 | 39 | 0 |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 | 58 | 0 |
| K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025-11-04 | 74 | 0 |
| K243905 | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 | 238 | 0 |
| K243740 | Versalock Upper Limb Plating System | GM Dos Reis Industria e Comercio Ltda. | 2025-01-29 | 56 | 0 |
| K242998 | GMReis Ankle Plating System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-21 | 56 | 0 |
| K242596 | Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-21 | 83 | 0 |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 | 88 | 0 |
| K232829 | Versalock Rib and Sternum Plates System | GM Dos Reis Industria e Comercio Ltda. | 2024-06-26 | 287 | 0 |
| K231684 | Quick - Radius Disposable Set | GM Dos Reis Industria e Comercio Ltda. | 2024-01-12 | 217 | 0 |
| K230397 | Cut Screw - Percutaneous Compression Screw | GM Dos Reis Industria e Comercio Ltda. | 2023-06-12 | 118 | 0 |
| K201728 | Versalock Periprosthetic Femur Plates System-GMReis | GM Dos Reis Industria e Comercio Ltda. | 2021-03-08 | 258 | 0 |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020-10-29 | 262 | 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