FDA.reportPublic FDA data

510(k) K232733

Device
Mbrace Cable
Applicant
Medacta International S.A.
510(k) number
K232733
Product code
JDQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-03
Date received
2023-09-07
Regulation
888.3010
Classification name
Cerclage, Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stefano Baj
Address
Strada Regina Castel San Pietro CH 6874 6874

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.2025-08-14
K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.2025-02-20
K233949ACCORD Cable SystemSmith & Nephew, Inc.2024-03-13
K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.2024-01-30
K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.2023-08-24
K231333STRETTO™ Cable SystemGlobus Medical, Inc.2023-08-04
K220765HS Fiber CerclageRiverpoint Medical, LLC2023-07-26
K221795STERN FIX Sternal Stabilization SystemNeos Surgery S.L2022-10-19
K211613Stern Fix Sternal Stabilization SystemNeos Surgery S.L2022-01-19
K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-10-28
K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020-10-16
K193479Sternal Cable SystemA & E Medical Corporation2020-03-23
K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-03-12
K181607Thorecon Rigid Fixation SystemA & E Medical Corporation2018-10-12
K173910Impress SFS SystemCable Fix Medical, LLC2018-09-14