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Data / Medical devices / South Korea / TDM Co.,ltd

TDM Co.,ltd: FDA-registered device maker in Buk-gu Gwangju, South Korea, 11 510(k) clearances

TDM Co.,ltd is registered with the FDA (registration 3014257776) in Buk-gu Gwangju, South Korea. It lists 23 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 5, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch TDM Co.,ltd
FDA registration number
3014257776
Address
69, Cheomdan Venture so-ro 37beon-gil, Buk-gu Gwangju, South Korea, 61003
Owner or operator
TDM Co.,Ltd (10057351)
Roles
Manufacturer
First device listed
March 25, 2018
Registered through
2026
Brand names listed
7.5mm Limited Sliding Locking Screw, Long(775101-2070~2110), 7.5mm Limited Sliding Locking Screw, Short(775001-2070~2110), Alignment Tube, Alignment Tube for Humerus Nail, Assemble Bolt, Assemble Bolt Driver, Assemble Bolt Driver For CHN, Assemble Bolt For CHN and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
Applier, Surgical, ClipGDO1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Burr, OrthopedicHTT1Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Drill, LigamentLXI1Manufactureraccessdata.fda.gov
Hook, BoneKIK1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Screwdriver, SurgicalLRZ1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Twister, WireHXS1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 5, 2024K241128TDM Plate and Screw SystemHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
August 22, 2024K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail SystemHSBSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
April 8, 2024K240423TDM Anterior Cervical Plate SystemKWQSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
April 5, 2024K232115TDM Large Bone Plate and Screw SystemHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
January 18, 2024K231860TDM Screw SystemHWCSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
August 17, 2022K221844TDM Lumbar Interbody Fusion Cage SystemMAXSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
May 19, 2022K220285PINE Pedicle Screw SystemNKBSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
March 19, 2020K191057Park's Pectus SystemHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
November 15, 2019K190391TDM Plate and Screw SystemsHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
September 13, 2019K190830TDM Screw SystemsHWCSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
March 15, 2018K171808TDM Plate and Screw SystemHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated December 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.