Home / 510(k) Clearances / K230071

510(k) K230071

Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System by Tdm Co., Ltd. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2024
Date Received
January 10, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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