510(k) K230397

Device
Cut Screw - Percutaneous Compression Screw
Applicant
GM Dos Reis Industria e Comercio Ltda.
510(k) number
K230397
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-12
Date received
2023-02-14
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Guilherme Esteves Pontes
Address
Avenida Pierre Simon De La Pl. 600 Campinas BR 13069-320 13069-320

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07899258659374Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-18
07899258659381Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-18
07899258659398Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-18
07899258659404Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-18
07899258659411Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-18
07899258659428Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-18
07899258659237Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659039Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659220Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659213Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659206Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659190Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659053Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659091Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659084Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659077Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659060Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659350Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659244Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659251Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659268Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659275Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659282Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659299Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659305Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659312Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659329Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659336Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659343Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16
07899258659367Cut Screw - Percutaneous Compression ScrewGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-16

Other 510(k) Records For Product Code HWC

510(k)DeviceApplicantDecision date
K261241TriMed Compression ScrewsTriMed, Inc.2026-05-14
K254215Arthrex Beaming SystemArthrex, Inc.2026-05-08
K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd.2026-05-01
K260934TITAN Nail; APTUS K-Wire SystemMedartis AG2026-04-17
K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics2026-04-10
K253042Tyber Medical Trauma ScrewTyber Medical, LLC2026-04-03
K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc.2026-03-18
K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.2026-03-06
K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-31
K251555Ultra™ Compression Screw SystemPace Surgical2025-11-06
K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev42025-10-10
K250536MetaFore Small Screw SystemExtremity Medical, LLC2025-10-08
K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27