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510(k) K212044

Device
TrueLok Evo
Applicant
Orthofix SRL
510(k) number
K212044
Product code
KTT  
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-05
Date received
2021-06-30
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

Applicant Contact#

Contact
Gianluca Ricadona
Address
Via Delle Nazioni 9 Bussolengo IT 37012 37012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KTT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC2026-10-02
K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC2026-06-11
K260900DYNEX® External Fixation SystemsVilex, LLC2026-04-17
K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.2026-03-23
K253291Excelsior SystemBlue Ocean Global2026-01-20
K253202Hoffmann LRF SystemStryker GmbH2025-12-19
K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.2025-12-19
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

Legacy Summary#

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FDA Review#

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