FDA.reportPublic FDA data

510(k) K242311

Device
EXPERT - Flexible Joint Fixation System
Applicant
GM Dos Reis Industria e Comercio Ltda.
510(k) number
K242311
Product code
HTN
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-01
Date received
2024-08-05
Regulation
888.3030
Classification name
Washer, Bolt Nut
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Guilherme Esteves Pontes
Address
Avenida Pierre Simon De Laplace, 600 Campinas BR 13069320 13069320

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HTN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252081SportLinc Syndesmosis DeviceLincotek Medical2026-03-27
K253727Syndesmosis TightRope PROArthrex, Inc.2025-12-22
K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)2025-10-29
K251134RipCordTriMed, Inc.2025-07-11
K243624Acu-Sinch Knotless MiniAcumed, LLC2025-01-23
K242091Bolo Button SystemFusion Orthopedics2024-12-23
K243408TACTIX Vector Syndesmosis SystemVilex, LLC2024-11-27
K240035TACTIX Vector Syndesmosis SystemVilex, LLC2024-08-01
K240947TENSOR® Suture Button SystemGlobus Medical, Inc.2024-06-03
K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024-02-02
K232780CC-Clip® Implant SystemCc-Instruments, Inc.2023-12-18
K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2023-10-06
K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2022-08-22
K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.2022-06-06
K220650TriMed Ripcord DeviceTriMed, Inc.2022-06-01