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510(k) K141912

Device
AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
510(k) number
K141912
Product code
KTT  
Decision
Substantially Equivalent (SESE)
Decision date
2014-10-29
Date received
2014-07-15
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
ANNA HWANG
Address
3203 Kashiwa St. Torrance CA US 90505 90505

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
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#

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