GM Dos Reis Industria e Comercio Ltda.: FDA clearances and approvals
GM Dos Reis Industria e Comercio Ltda. has 16 FDA 510(k) clearances (first 2020, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time: 86 days. Since 2017 its median was 86 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 262 |
| 2021 | 1 | 258 |
| 2022 | 0 | — |
| 2023 | 1 | 118 |
| 2024 | 5 | 88 |
| 2025 | 3 | 74 |
| 2026 | 5 | 58 |
Review time against the same product codes
Since 2017, GM Dos Reis Industria e Comercio Ltda.'s cleared 510(k)s took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 9 | 9 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
| HTN | Washer, Bolt Nut | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
Most recent GM Dos Reis Industria e Comercio Ltda. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253910 | Stitch - Suture Wires and Tapes | GAT | 2026-08-22 | 257 |
| K262537 | Versalock Sterile Plating System | HRS | 2026-08-19 | 27 |
| K261406 | Versalock Proximal Tibial Plating System | HRS | 2026-07-21 | 83 |
| K260390 | Super Upper Limbs Versalock Plating System | HRS | 2026-03-17 | 39 |
| K254188 | Meniscus Versaflex | GAT | 2026-02-19 | 58 |
| K252664 | GMReis Suture Anchors | MBI | 2025-11-04 | 74 |
| K243905 | Stitch Cerclage Suture Tapes | JDQ | 2025-08-14 | 238 |
| K243740 | Versalock Upper Limb Plating System | HRS | 2025-01-29 | 56 |
| K242998 | GMReis Ankle Plating System | HRS | 2024-11-21 | 56 |
| K242596 | Versalock Mini and Micro Plating System | HRS | 2024-11-21 | 83 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named GM Dos Reis Industria e Comercio Ltda..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does GM Dos Reis Industria e Comercio Ltda. have?
GM Dos Reis Industria e Comercio Ltda. has 16 FDA 510(k) clearances (first 2020, latest 2026), across 6 product codes in 2 review panels.
How long does FDA take to clear GM Dos Reis Industria e Comercio Ltda.'s 510(k)s?
The median time from FDA receipt to decision across GM Dos Reis Industria e Comercio Ltda.'s cleared 510(k)s is 86 days. Since 2017: 86 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does GM Dos Reis Industria e Comercio Ltda. make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 9); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 2); HTN (Washer, Bolt Nut, 2).
Has GM Dos Reis Industria e Comercio Ltda. had device recalls?
openFDA lists no recalls under a recalling firm name matching GM Dos Reis Industria e Comercio Ltda. Related entities may recall under other names.
Next steps
- See all 16 GM Dos Reis Industria e Comercio Ltda. clearances with predicates and recalls
- Run predicate analysis for product code HRS, GM Dos Reis Industria e Comercio Ltda.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.