Tdm Co., Ltd. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
TDM Plate and Screw System510(k)Dec 5, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 5, 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System510(k)Aug 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 22, 2024
TDM Anterior Cervical Plate System510(k)Apr 8, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 8, 2024
TDM Large Bone Plate and Screw System510(k)Apr 5, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 5, 2024
TDM Screw System510(k)Jan 18, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 18, 2024
TDM Lumbar Interbody Fusion Cage System510(k)Aug 17, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 17, 2022
PINE Pedicle Screw System510(k)May 19, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 19, 2022