FDA.report

510(k) K200062

Device
Foot and Ankle System
Applicant
Leith Medical, LLC
510(k) number
K200062
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-22
Date received
2020-01-13
Regulation
888.3030
Classification name
Plate, Fixation, Bone
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
Tim Leak
Address
4705 Eagle Feather Dr. Austin TX US 78735 78735

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
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B9530500TRIALR0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530800TRIALL0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530200TRIALR0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530500TRIALL0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530100TRIAL0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530600TRIAL0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530300TRIAL0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530400TRIALR0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530700TRIALL0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530800TRIALR0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530700TRIALR0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
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B9530101TRIAL0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B9530200TRIALS0Leith Medical Plating System InstrumentsLeith Medical LLC2023-10-06
B953103500280Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500140Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500260Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500220Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500120Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953102700600Leith Medical 2.7mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500240Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500180Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953102700580Leith Medical 2.7mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500300Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500100Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05
B953103500320Leith Medical 3.5mm Cortical ScrewLeith Medical LLC2023-10-05

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