Is this your brand? Sign in to claim ownership.
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
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (1723)
Page 19 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GMReis Ankle Plating System | CANCELLOUS SCREW 4.0X14X35MM | FDA UDI | Class II | Active |
| Cut Screw - Percutaneous Compression Screw | Cut Screw | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Olecranon Versatile Plate Right 05 Holes 2.7/3.5 mm | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Locking Screw | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | VA Cannulated Screw | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | Cortical Screw | FDA UDI | Class II | Active |
| Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Mini HTA | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Micro Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | WATERSHED DISTAL RADIUS VERSALOCK LOCKING PLATE 50.0MM X 23.0MM – STANDARD – LEF | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Olecranon Versatile Plate Left 12 Holes 2.7/3.5 mm | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 15 HOLES - 2.7/3.5 | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | VA Cannulated Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Micro Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | VERSALOCK VOLAR BABY FOOT LOCKED PLATE D 70,0MM X 27,0MM | FDA UDI | Class II | Unknown |
| GMReis Ankle Plating System | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 06 HOLES 2.7/3.5MM | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Locking Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Mini Cortical Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Mini Cortical Screw | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5X60MM T10 | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Antero Medial Clavicle Plate 04 Holes 3.5mm | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | PLATE | FDA UDI | Class II | Unknown |
| Pedimax II - Pedicular Screw Spinal System | Monoaxial Pedicle Screw | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | MINI CANNULATED COMPRESSION SCREW PARTIAL LONG THREAD Ø 4.0X30X60MM | FDA UDI | Class II | Active |
| Cut Screw - Percutaneous Compression Screw | Cut Screw | FDA UDI | Class II | Active |
| Orthopedic Instruments | PLATES CUTTING PLIER | FDA UDI | Class I | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | Condilar Plate | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5/2.7MMX60MM T10 | FDA UDI | Class II | Active |
| Versalock Rib and Sternum Plates System | Versalock Rib and Sternum Screw–T7 Self Drilling Ø2.4 x 7.0mm | FDA UDI | Class II | Active |
| Versalock Rib and Sternum Plates System | “H” Versalock Sternum Plate - 08 Holes | FDA UDI | Class II | Active |
| Versalock Upper Limb Plating System | Versalock Olecranon Versatile Plate Left 07 Holes 2.7/3.5 mm | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5X24MM T10 | FDA UDI | Class II | Active |
| Versalock Periprosthetic Femur Plates System-GMReis | VA Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Cortical Screw | FDA UDI | Class II | Active |
| Pedimax II - Pedicular Screw Spinal System | Rod | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 18 HOLES 2.7/3.5MM | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Mini Cortical Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Mini Cortical Screw | FDA UDI | Class II | Active |
| Pedimax II - Pedicular Screw Spinal System | Rod to Rod Clamp | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Mini Cortical Screw | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 13 HOLES - 2.7/3.5 | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Micro Screw | FDA UDI | Class II | Active |
| Pedimax II - Pedicular Screw Spinal System | Monoaxial Pedicle Screw | FDA UDI | Class II | Active |
| Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Max HTA | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | Micro Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | VERSALOCK VOLAR BABY FOOT LOCKED PLATE E 45,0MM X 23,0MM | FDA UDI | Class II | Unknown |
| Mini and Micro Fragments Reconstruction System - GMReis | Micro Screw | FDA UDI | Class II | Active |
| GMReis Ankle Plating System | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 10 HOLES 2.7/3.5MM | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | PLATE | FDA UDI | Class II | Unknown |
| Versalock Periprosthetic Femur Plates System-GMReis | Cortical Screw | FDA UDI | Class II | Active |
| Mini and Micro Fragments Reconstruction System - GMReis | VERSALOCK VOLAR BABY FOOT LOCKED PLATE E 56,0MM X 27,0MM | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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