BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TDM USA INC.

    Reg #: 3031261833 · FEI: 3031261833 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    105
    Establishment Types
    1
    Classifications
    21

    Registration Details

    Registration Name
    TDM USA INC.
    Registration Number
    3031261833
    FEI Number
    3031261833
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4020 215th Street
    City
    Bayside
    State
    NY
    ZIP
    11361
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171808

    Owner / Operator

    Firm Name
    TDM USA INC.
    Operator Number
    10090919
    Address
    4020 215th Street
    City
    Bayside
    State
    NY
    Postal Code
    11361
    Country
    US
    Correspondent
    Minjeong Kim-Jin

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Rod, Fixation, Intramedullary And Accessories HSB
    Gauge, Depth HTJ
    Bender HXW
    Washer, Bolt Nut HTN
    Applier, Surgical, Clip GDO
    Cutter, Wire HXZ
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Reamer HTO
    Thoracolumbosacral Pedicle Screw System NKB
    Hook, Bone KIK
    Screwdriver, Surgical LRZ
    Bit, Drill HTW
    Twister, Wire HXS
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Forceps HTD
    Burr, Orthopedic HTT
    Instrument, Compression HWN
    Screwdriver HXX

    Proprietary Names

    Trifix plate and screw system TDM Plate and screw system TDM Intramedullary Fixation Nailing System MIFix Depth Gauge (904003-0001) Depth Gauge Pate Bending Piler, Flat Bender Bender, Small TDM Screw Systems Fixator Clip Applier TDM Plate and Screw Systems Plate Cutter TDM Anterior Cervical Plate System Reamer for 1st MTP Reamer Guide for 1st MTP PINE Pedicle Screw System TDM Large Bone Plate and Screw System Bone Hook Fixator Driver MIFix Cannular Drill Bit (904002-0019, 904002-0024) Drill Bit Cannulated Drill Bit Drill Bit, AO Chuck Bone Awl 10mm Bone Awl, 5mm Easy Crane System(PPM-100) Introduce Director (PPM-124) Screw Driver Shaft MIFix Guide Pin Trocar Type(904001-0011, 904001-0013) Supporting Bar(PPM-104) MIFix Guide Pin Dispenser(904011-0011, 904011-0013) Template Bar(PPM-210TP, PPM-212TP, PPM-214TP, PPM-216TP) Locking Drill Sleeve, Single Handle, for Small Head Insert Pin Guide Drilling Block, Distal Fibular Spoon/Hole Locking Drill Sleeve Drilling Block, DRLP, Intra Articular Bottom Post(PPM-102) Table Top Bender(PMI-020) Locking Drill Sleeve, Single Handle Quick Chuck T-Handle Torque Limit Handle Bar Introducer Small(PMI-022) MIFix Perio(919-10000) MIFix Double sleeve handle(904005-1220, 904005-1425) Drilling Block, DRLP, Intra Articular, Small Flare Buster Tunneler(PMI-072) Pectus Crane Screw(PSF-1208, PSF-1210, PSF-1212, PSF-1214, PSF-1216) Pectus Crane Screw(PSF-3208, PSF-3210, PSF-3212, PSF-3214, PSF-3216) Broken Hexa Remove Driver Shaft Bar Introducer Large(PMI-023) Bar Positioning Hook(PMI-053) Drilling Block, Fibular, Posterior Temporary Fixation K-wire Cannulated Quick Chuck Drill Sleeve, Single Handle Cannulated Tap with T-Handle Parallel Drill Guide Handheld Bar Bender(PMI-021) Drilling Block, Distal Tibia, Posterior MIFix Cannular Handle(904004-1001) Countersink with Measuring Device T-Handle Pectus Crane Screw(PSF-908, PSF-910, PSF-912, PSF-914, PSF-916) Fixator Clip Applier(PPM-011) Cannulated Depth Gauge DCP Drill Guide Cannulated Screw Driver Drilling Block, PHLP Fixator Driver(PPM-010) Rod Introducer (PPM-123) Drilling Block, Distal Tibia, Anterior Pectus Crane Screw(PSF-1108, PSF-1110, PSF-1112, PSF-1114, PSF-1116) Guide wire, Non-Threaded Flare Buster Compressor Pectus Crane Screw(PSF-1008, PSF-1010, PSF-1012, PSF-1014, PSF-1016) Drilling Block, Distal Modified Clamp(PPM-013) MIFix Cannular Driver Shaft(904004-0008, 904004-0010) Crane Elevator(PPM-106) Guide Wire Hercules Bar Removal Bender(PPM-012) Drilling Block, Fibular, Lateral Cannulated Screw Driver Shaft Plate Hodling Sleeve (Solid) Pectus Crane Screw(PSF-4208, PSF-4210, PSF-4212, PSF-4214, PSF-4216) Locking Drill Sleeve, for Small Head Modified Filpper(PPM-015) Park's Pectus System TDM Screw System 7.5mm Limited Sliding Locking Screw, Short(775001-2070~2110) MIFix Cannulated Screw 3mm(793001-1020~1050) 7.5mm Limited Sliding Locking Screw, Long(775101-2070~2110) MIFix Cannulated Screw 3.5mm(793501-1022~1064) TDM Lumbar Interbody Fusion Cage System Holding Forcep MIFix Burr (904111-2008, 904111-2012, 904111-2022, 904111-2222, 904111-2913, 904111-3012, 904111-3030, 904111-4313) Compressing Plate(PPM-206) Flare Compressor(PPM-200) Supporting Cross Bar(PPM-204) Carinatum Hook Bar Puller(PPM-208) Bottom Post(PPM-202) Crane Screw Driver(PCS-302) Screw Driver Shaft, Holding Crane Screw Driver(PCS-301) Screw Driver, Holding

    Establishment Types

    Repack or Relabel Medical Device