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Mini and Micro Fragments Reconstruction System – GMReis

by Gm Dos Reis Industria E Comerico Ltda.

510(k) K182718

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182718 Date23 Dec 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mini and Micro Fragments Reconstruction System – GMReis is a bone reconstruction device designed for the stabilization and fixation of small to medium-sized bone fragments. Classified under product code HRS (Hydroxyapatite or Resorbable Bone Graft Substitutes), it is intended for orthopedic applications involving interfragmentary compression and internal fixation techniques. The system comprises components engineered to reconstruct fragmented bone segments, aiding in the restoration of structural integrity during surgical procedures. Its construction aligns with orthopedic reconstruction principles, ensuring compatibility with established clinical practices.

This system is supplied as a sterile, single-use device and is intended for invasive orthopedic use under sterile conditions. It is not MRI-safe and must be handled in accordance with standard surgical protocols. The system is available in configurations tailored for mini and micro fragment reconstruction, with components sized for precise application in orthopedic trauma or reconstructive surgeries. Authorized under FDA 510(k) clearance (K182718), it adheres to regulatory standards for orthopedic reconstruction devices, ensuring compliance with 21 CFR 888.3030. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.

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