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Sign in to claim this brandGm Dos Reis Industria E Comercio
US
Last updated May 23, 2026
What Gm Dos Reis Industria E Comercio makes
Gm Dos Reis Industria E Comercio manufactures the Pectus Versa System, designed for surgical correction of pectus excavatum deformities, and the GMReis Fibula Nail System, used in orthopedic fixation for long bone fractures, particularly the tibia.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates within the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gm Dos Reis Industria E Comercio manufacture?
Gm Dos Reis Industria E Comercio specializes in surgical devices for orthopedic and thoracic applications. Their portfolio includes the Pectus Versa System, which is intended for correcting pectus excavatum deformities (a sunken chest condition), and the GMReis Fibula Nail System, designed for internal fixation of long bone fractures, particularly in the tibia. These devices address distinct clinical needs in orthopedic and reconstructive surgery.
Where is Gm Dos Reis Industria E Comercio based, and what does that mean for its regulatory oversight?
The company is based in the United States, meaning its devices fall under FDA jurisdiction. Since the devices are classified as Class II, they require premarket notification (510(k)) clearance before commercial distribution. This classification reflects a moderate risk level, requiring evidence of substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Gm Dos Reis Industria E Comercio’s devices?
Gm Dos Reis Industria E Comercio’s devices are listed in the FDA’s 510(k) database, which tracks premarket notifications for Class II devices. This registry confirms the devices have undergone the required FDA review process for safety and effectiveness before entering the market. The listing serves as a public record of compliance with U.S. regulatory requirements.
How are Gm Dos Reis Industria E Comercio’s devices classified under FDA regulations, and why does this matter?
The company’s devices are classified as Class II under FDA regulations, indicating a moderate risk to patients. This classification requires manufacturers to demonstrate that their devices are substantially equivalent to a legally marketed predicate device through the 510(k) pathway. The classification ensures additional scrutiny beyond general controls (like manufacturing standards) but does not require the rigorous clinical trials associated with Class III devices, which pose higher risks.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (1723)
Page 35 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Suture Fisher Hip | Suture Holder 45° to the Right | FDA UDI | Class I | Active |
| Meniscus Suture - OUT IN | Meniscus Suture - OUT IN | FDA UDI | Class I | Active |
| Orthopedic Instruments | CASE SUPER HAND Ø1,3 Ø1,5mm Ø1,8 | FDA UDI | Class I | Active |
| Orthopedic Instruments | Ø2,0x35,0x110,0mm DRILL | FDA UDI | Class I | Active |
| Orthopedic Instruments | DRILL DIAM.2.7X85.0MM | FDA UDI | Class I | Active |
| MICA Guide | MICA Hex Wrench | FDA UDI | Class I | Active |
| Orthopedic Instruments | DRILL GUIDE DIAM.1.1 MM | FDA UDI | Class I | Active |
| Percutaneous Foot Burrs, Arthodesis Burrs | Burrs Cylindrical | FDA UDI | Class I | Active |
| Quick - Radius Disposable Set | K231684 | FDA 510(k)FDA UDI | Class II | Active |
| EXPERT - Flexible Joint Fixation System | K242311 | FDA 510(k) | Class II | Active |
| Stitch Cerclage – Suture Tapes | K243905 | FDA 510(k) | Class II | Active |
| Versalock Mini and Micro Plating System | K242596 | FDA 510(k) | Class II | Active |
| GMReis Ankle Plating System | K242998 | FDA 510(k) | Class II | Active |
| Super Upper Limbs Versalock Plating System | K260390 | FDA 510(k) | Class II | Active |
| Meniscus Versaflex | K254188 | FDA 510(k) | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | K201728 | FDA 510(k) | Class II | Active |
| EXPERT - Joint Fixation System | K200332 | FDA 510(k) | Class II | Active |
| Versalock Rib and Sternum Plates System | K232829 | FDA 510(k)FDA UDI | Class II | Active |
| Cut Screw - Percutaneous Compression Screw | K230397 | FDA 510(k) | Class II | Active |
| Pectus Versa System | K251050 | FDA 510(k) | Class II | Active |
| Versalock Upper Limb Plating System | K243740 | FDA 510(k) | Class II | Active |
| GMReis Suture Anchors | K252664 | FDA 510(k) | Class II | Active |
| GMReis Fibula Nail System | K250559 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Gm Dos Reis Industria E Comercio Ltda Campinas Sao Paulo · BR FEI 3013756169