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Data / Medical devices / United States / TDM Usa Inc.

TDM Usa Inc.: FDA-registered device maker in Bayside, NY, United States, 10 510(k) clearances

TDM Usa Inc. is registered with the FDA (registration 3031261833) in Bayside, NY, United States. It lists 21 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 22, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3031261833
Address
4020 215th Street, Bayside, NY, United States, 11361
Owner or operator
TDM USA INC. (10090919)
Roles
Repackager or relabeler
First device listed
June 2, 2024
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), Bar Introducer Large(PMI-023), Bar Introducer Small(PMI-022), Bar Positioning Hook(PMI-053), Bender, Bender, Small, Bone Awl 10mm and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Repackager or relabeleraccessdata.fda.gov
BenderHXW1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Burr, OrthopedicHTT1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Hook, BoneKIK1Repackager or relabeleraccessdata.fda.gov
Instrument, CompressionHWN1Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
Plate, Fixation, BoneHRS2Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Repackager or relabeleraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, BoneHWC2Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Screwdriver, SurgicalLRZ1Repackager or relabeleraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Repackager or relabeleraccessdata.fda.gov
Twister, WireHXS1Repackager or relabeleraccessdata.fda.gov
Washer, Bolt NutHTN2Repackager or relabeleraccessdata.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
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 August 22, 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.