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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 34 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orthopedic Instruments | COUNTERSINK FOR DIAM.1.3 MM AND DIAM.1.5 MM LAG SCREW | FDA UDI | Class I | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Mini H Plate | FDA UDI | Class II | Active |
| Cut Screw - Percutaneous Compression Screw | Cut Screw | FDA UDI | Class II | Active |
| Orthopedic Instruments | GUIDE WIRE DIAM.1.25 MM X 150.0 MM | FDA UDI | Class I | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Locking Screw | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Superior Lateral Right Clavicle Plate 14 Holes 2.7/3.5mm | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Cortical Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Locking Screw | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | VERSALOCK TORXDRIVE LOCKING SCREW LOW PROFILE Ø3.5/2.7MM X14MM T10 | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Locking Screw | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | VERSALOCK LOCKING SCREW T15 Ø3.5X100.0MM | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Mini L Plate | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | VA Periprosthetic Screw | FDA UDI | Class II | Active |
| Orthopedic Instruments | 333-SC-400 | FDA UDI | Class I | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | PLATE | FDA UDI | Class II | Unknown |
| Versalock Periprosthetic Femur Plates System-GMReis | VA Screw | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Superior Lateral Clavicle Plate with Anterior Tab Right 16 Holes 2.7/3 | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Olecranon Plate Left 06 Holes 2.7mm | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Superior Medial Small Right Clavicle Plate 08 Holes 3.5mm | FDA UDI | Class II | Active |
| Pedimax II - Pedicular Screw Spinal System | Monoaxial Pedicle Screw | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Olecranon Versatile Plate Right 04 Holes 2.7/3.5 mm | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Cuboid Plate | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | Cortical Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Locking Screw | FDA UDI | Class II | Active |
| Pedimax II - Pedicular Screw Spinal System | Rod to Rod Clamp | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5X14MM T10 | FDA UDI | Class II | Active |
| Cut Screw - Percutaneous Compression Screw | Cut Screw | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | VA Screw | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | VA Cannulated Screw | FDA UDI | Class II | Active |
| Suture Fisher | Crescent Suture Holder | FDA UDI | Class I | Active |
| Orthopedic Instruments | WIRE GUIDE 2.0 X 150MM | FDA UDI | Class I | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Baby Foot Plate | FDA UDI | Class II | Active |
| Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Fix Super Max Zip Anchor | FDA UDI | Class II | Active |
| Orthopedic Instruments | DOUBLE DRILL GUIDE DIAM.1.5 MM X DIAM.1.1MM | FDA UDI | Class I | Active |
| Orthopedic Instruments | CABLE WITH TORQUE LIMITER 0,8NM | FDA UDI | Class I | Active |
| Orthopedic Instruments | Ø2,7x30,0x85,0mm DRILL | FDA UDI | Class I | Active |
| Orthopedic Instruments | DRILL BIT DIAM.1.0 MM X 31.0 MM X 75.0 MM | FDA UDI | Class I | Active |
| Orthopedic Instruments | T7 HEXALOB SHAFT DRIVER | FDA UDI | Class I | Active |
| Disposable Kit for MIRO Procedure Gmreis | MIRO Tip | FDA UDI | Class I | Active |
| MICA Guide | MICA Guide | FDA UDI | Class I | Active |
| Orthopedic Instruments | VERSALOCK MICRO PLATES PIN BENDER | FDA UDI | Class I | Active |
| Orthopedic Instruments | 333-SC-320 | FDA UDI | Class I | Active |
| Orthopedic Instruments | FIXED DRILL GUIDE DIAM.2.0MM | FDA UDI | Class I | Active |
| Orthopedic Instruments | FIXED DRILL GUIDE DIAM.1.8MM | FDA UDI | Class I | Active |
| Suture Fisher Hip | Suture Holder 45° to the Left | FDA UDI | Class I | Active |
| Orthopedic Instruments | DRILL DIAM.2.0X110.0MM | FDA UDI | Class I | Active |
| Orthopedic Instruments | BOX SUPER HAND | FDA UDI | Class I | Active |
| Orthopedic Instruments | INTERFRAGMENTARY DRILL GUIDE DIAM.2.4MM | FDA UDI | Class I | Active |
| Percutaneous Foot Burrs, Arthodesis Burrs | Burrs Conical | FDA UDI | Class I | Active |
| Orthopedic Instruments | Ø2,0x41,0x71,0mm DRILL | FDA UDI | Class I | 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