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Gm Dos Reis Industria E Comercio

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
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Catalogue (1723)

Page 4 of 35

Device	Model / Reference	Registries	Class	Status
Orthopedic Instruments	Ø2,7x30,0x150,0mm DRILL	FDA UDI	Class I	Active
Versalock Upper Limb Plating System	Versalock Lateral Distal Humerus Plate Right 09 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	Mini Y Plate	FDA UDI	Class II	Active
GMReis Ankle Plating System	CANCELLOUS SCREW 4.0X7X18MM	FDA UDI	Class II	Active
Pedimax II - Pedicular Screw Spinal System	Monoaxial Pedicle Screw	FDA UDI	Class II	Active
Cut Screw - Percutaneous Compression Screw	Cut Screw	FDA UDI	Class II	Active
Mini and Micro Fragments Reconstruction System - GMReis	VERSALOCK VOLAR BABY FOOT LOCKED PLATE E 100,0MM X 27,0MM	FDA UDI	Class II	Unknown
Pedimax II - Pedicular Screw Spinal System	Polyaxial Pedicle Screw Porous	FDA UDI	Class II	Active
Mini and Micro Fragments Reconstruction System - GMReis	Semilunar Plate	FDA UDI	Class II	Active
Cut Screw - Percutaneous Compression Screw	Cut Screw	FDA UDI	Class II	Active
Pedimax II - Pedicular Screw Spinal System	Rod to Rod Clamp	FDA UDI	Class II	Active
Versalock Upper Limb Plating System	Versalock Lateral Distal Humerus Plate Right 12 Holes 2.7/3.5mm	FDA UDI	Class II	Active
Micro Easypass	MICRO EASYPASS - LARGE CURVED MICRO SUTURE PASSER	FDA UDI	Class I	Active
Mini and Micro Fragments Reconstruction System - GMReis	Locking Screw	FDA UDI	Class II	Active
Mini and Micro Fragments Reconstruction System - GMReis	Cortical Screw	FDA UDI	Class II	Active
Quick - Radius Disposable Set	Quick - Radius Disposable Set - Large Plate Left and Screws	FDA UDI	Class II	Active
Mini and Micro Fragments Reconstruction System - GMReis	Mini L Plate	FDA UDI	Class II	Active
EXPERT - Joint Fixation System	Mini EXPERT	FDA UDI	Class II	Active
EXPERT - Flexible Joint Fixation System	EXPERT ACL with augmentation	FDA UDI	Class II	Active
EXPERT - Flexible Joint Fixation System	EXPERT ACL TIBIAL TAPE - 20mm/9mm	FDA UDI	Class II	Active
Versalock Periprosthetic Femur Plates System-GMReis	Proximal Femur Plate	FDA UDI	Class II	Active
Mini and Micro Fragments Reconstruction System - GMReis	Micro Y Plate	FDA UDI	Class II	Active
GMReis Ankle Plating System	ANATOMICAL FIBULA VERSALOCK PLATE LEFT 06 HOLES - 2.7/3.5	FDA UDI	Class II	Active
GMReis Ankle Plating System	VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5/2.7MMX38MM T10	FDA UDI	Class II	Active
Versalock Periprosthetic Femur Plates System-GMReis	Cortical Screw	FDA UDI	Class II	Active
GMReis Ankle Plating System	VERSALOCK LOCKING SCREW TI T7 Ø2.7X76.0MM	FDA UDI	Class II	Active
Percutaneous Foot Burrs, Arthodesis Burrs	Burrs Spheric	FDA UDI	Class I	Active
Mini and Micro Fragments Reconstruction System - GMReis	Cortical Screw	FDA UDI	Class II	Active
Cut Screw - Percutaneous Compression Screw	Cut Screw	FDA UDI	Class II	Active
Orthopedic Instruments	WIRE GUIDE DIAM.1.0 X 127.0MM	FDA UDI	Class I	Active
Cut Screw - Percutaneous Compression Screw	Cut Screw - Sterile	FDA UDI	Class II	Active
GMReis Ankle Plating System	VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5/2.7MMX40MM T10	FDA UDI	Class II	Active
Versalock Periprosthetic Femur Plates System-GMReis	Cortical Screw	FDA UDI	Class II	Active
Versalock Rib and Sternum Plates System	Wave Versalock Rib Plate - 28 Holes	FDA UDI	Class II	Active
Versalock Periprosthetic Femur Plates System-GMReis	VA Screw	FDA UDI	Class II	Active
Cut Screw - Percutaneous Compression Screw	Cut Screw	FDA UDI	Class II	Active
Pedimax II - Pedicular Screw Spinal System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
Versalock Rib and Sternum Plates System	Versalock Rib and Sternum Screw–T7 Self Drilling Ø2.4 x 12.0mm	FDA UDI	Class II	Active
GMReis Ankle Plating System	VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5/2.7MMX26MM T10	FDA UDI	Class II	Active
Versalock Upper Limb Plating System	Versalock Scapular Acromion Plate Right 07 Holes 3.5mm	FDA UDI	Class II	Active
Mini and Micro Fragments Reconstruction System - GMReis	Hook 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	Cortical Screw	FDA UDI	Class II	Active
Orthopedic Instruments	PLATE BENDING	FDA UDI	Class I	Active
Mini and Micro Fragments Reconstruction System - GMReis	Micro Screw	FDA UDI	Class II	Active
Versalock Upper Limb Plating System	Versalock Superior Medial Right Clavicle Plate 04 Holes 3.5mm	FDA UDI	Class II	Active
Versalock Periprosthetic Femur Plates System-GMReis	VA Locking Screw	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	Locking Screw	FDA UDI	Class II	Active

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Gm Dos Reis Industria E Comercio Ltda Campinas Sao Paulo · BR FEI 3013756169