Medical Device Manufacturer · BR , Campinas

GM Dos Reis Industria e Comercio Ltda.

12 submissions · 12 cleared · Since 2020
12
Total
12
Cleared
0
Denied

GM Dos Reis Industria e Comercio Ltda. — FDA 510(k) Submissions

GM Dos Reis Industria e Comercio Ltda. has submitted 12 FDA 510(k) premarket notifications since 2020, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Washer, Bolt Nut, Screw, Fixation, Bone, Cerclage, Fixation, Fastener, Fixation, Nondegradable, Soft Tissue . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Meniscus Versaflex
K254188 · GAT Suture, Nonabsorbable,... · Orthopedic
Feb 2026 58d
GMReis Suture Anchors
K252664 · MBI Fastener, Fixation,... · Orthopedic
Nov 2025 74d
Stitch Cerclage ? Suture Tapes
K243905 · JDQ Cerclage, Fixation · Orthopedic
Aug 2025 238d
Versalock Upper Limb Plating System
K243740 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2025 56d
Versalock Mini and Micro Plating System
K242596 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2024 83d
GMReis Ankle Plating System
K242998 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2024 56d
EXPERT - Flexible Joint Fixation System
K242311 · HTN Washer, Bolt Nut · Orthopedic
Nov 2024 88d
Versalock Rib and Sternum Plates System
K232829 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2024 287d
Quick - Radius Disposable Set
K231684 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2024 217d
Cut Screw - Percutaneous Compression Screw
K230397 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2023 118d
Versalock Periprosthetic Femur Plates System-GMReis
K201728 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2021 258d
EXPERT - Joint Fixation System
K200332 · HTN Washer, Bolt Nut · Orthopedic
Oct 2020 262d
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