FDA.report

510(k) K231333

Device
STRETTO™ Cable System
Applicant
Globus Medical, Inc.
510(k) number
K231333
Product code
JDQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-04
Date received
2023-05-08
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jennifer Antonacci
Address
2560 General Armistead Ave. Audubon PA US 19403 19403

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00193982513962STRETTOGLOBUS MEDICAL, INC.2023-09-28
00193982511227STRETTOGLOBUS MEDICAL, INC.2023-09-28
00193982511210STRETTOGLOBUS MEDICAL, INC.2023-09-28
00193982511203STRETTOGLOBUS MEDICAL, INC.2023-09-28

Other 510(k) Records For Product Code JDQ

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
K232733Mbrace CableMedacta International S.A.2024-05-03
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
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