FDA.report

510(k) K052605

Device
EXTERNAL FIXATION
Applicant
GEXFIX USA INC.
510(k) number
K052605
Product code
KTT  
Decision
Substantially Equivalent (SESE)
Decision date
2005-11-10
Date received
2005-09-21
Regulation
888.3030
Classification name
Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
LUCIO IMPROTA
Address
1200 Clint Moore Rd., Suite 1 Boca Raton FL US 33487 33487

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07640136270118External Fixator Reduction sleeve 9/3GEXFIX SA2016-09-30
07640136270255External Fixator Carbon Ring Ø 160GEXFIX SA2016-09-30
07640136270248External Fixator Lengthening / compression tube smGEXFIX SA2016-09-30
07640136270231External Fixator Lengthening / compression tubeGEXFIX SA2016-09-30
07640136270200External Fixator Pin cluster clamp 9/9GEXFIX SA2016-09-30
07640136270194External Fixator Carbon rod 9x200GEXFIX SA2016-09-30
07640136270187External Fixator Carbon rod 9x150GEXFIX SA2016-09-30
07640136270170External Fixator Carbon rod 9x110GEXFIX SA2016-09-30
07640136270163External Fixator Carbon rod 9x90GEXFIX SA2016-09-30
07640136270156External Fixator Carbon rod 9x70GEXFIX SA2016-09-30
07640136270132External Fixator Reduction sleeve 9/5GEXFIX SA2016-09-30
07640136270125External Fixator Reduction sleeve 9/4GEXFIX SA2016-09-30
07640136270262External Fixator Carbon ring Ø 200GEXFIX SA2016-09-30
07640136270101External Fixator Connection 9 / 9GEXFIX SA2016-09-30
07640136270095External Fixator Carbon tube 15x250GEXFIX SA2016-09-30
07640136270088External Fixator Carbon tube 15x200GEXFIX SA2016-09-30
07640136270071External Fixator Carbon Tube 15x150GEXFIX SA2016-09-30
07640136270064External Fixator Carbon tube 15x125GEXFIX SA2016-09-30
07640136270057External Fixator Carbon tube 15x100GEXFIX SA2016-09-30
07640136270040External Fixator Reduction sleeve 15/9GEXFIX SA2016-09-30
07640136270033External Fixator Reduction sleeve 15/5GEXFIX SA2016-09-30
07640136270026External Fixator Reduction sleeve 15/4GEXFIX SA2016-09-30
07640136270019External Fixator Pin cluster clamp 15 Stainless stGEXFIX SA2016-09-30
07640136270002External Fixator Connection 15/15GEXFIX SA2016-09-30
07640136270439External Fixator Transfixing pin 4/5x200GEXFIX SA2016-09-30
07640136270545External Fixator Sterilization box small GEXFIX SA2016-09-30
07640136270538External Fixator Sterilization box large standardGEXFIX SA2016-09-30
07640136270521External Fixator Cutting plyerGEXFIX SA2016-09-30
07640136270514External Fixator TensionerGEXFIX SA2016-09-30
07640136270507External Fixator Trocar and handle smallGEXFIX SA2016-09-30

Other 510(k) Records For Product Code KTT  

510(k)DeviceApplicantDecision date
K260900DYNEX® External Fixation SystemsVilex, LLC2026-04-17
K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.2026-03-23
K253291Excelsior SystemBlue Ocean Global2026-01-20
K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.2025-12-19
K253202Hoffmann LRF SystemStryker GmbH2025-12-19
K252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC2025-11-25
K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC2025-11-20
K252106External Fixation Mini Rail SystemParagon 28, Inc.2025-09-30
K251862External Fixation Bone DistractorParagon 28, Inc.2025-08-11
K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.2025-08-08
K251128Extremity Medical External Fixation SystemExtremity Medical, LLC2025-05-07
K243798Orthex External Fixation SystemOrthoPediatrics Corp.2025-03-07
K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025-02-21
K242861TrueLok ElevateOrthofix Srl2024-12-03
K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.2024-11-01

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases