FDA Registration Active 🇰🇷 South Korea

TDM CO.,LTD

Reg #: 3014257776 · FEI: 3014257776 · Expires 2026
Products
23
Proprietary Names
280
Establishment Types
1
Classifications
23

Registration Details

Registration Name
TDM CO.,LTD
Registration Number
3014257776
FEI Number
3014257776
Status
Active
Expiry Year
2026
Initial Importer
No
Address
69, Cheomdan Venture so-ro 37beon-gil
City
Gwangju
Country
KR

Regulatory Submissions

510(k) Number
K230071

Owner / Operator

Firm Name
TDM Co.,Ltd
Operator Number
10057351
Address
69, Cheomdan Venture so-ro 37beon-gil
City
Gwangju
State
KR-29
Postal Code
61003
Country
KR
Correspondent
JungWook Choi

US Agent

Business Name
TDM USA Inc.
Contact Name
Pia Kim
Address
4020 215th St
City
Bayside
State
NY
ZIP
11361
Country
US
Phone
347 5232334

Products

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

Proprietary Names

Fixator Clip Applier Bender Bender, Small Plate Bending Plier, Flat Plate Cutting Bending Plier MIFix Depth Gauge (904003-0001) Step Drill Stopper Direct Measuring Device for CHN Depth Gauge Cannulated Measuring Device Space Measuring Device Direct Measuring Device Measuring Device Nail Measuring Plate Cannulated with Measuring Device T-Handle Measuring Device 2 TDM Intramedullary Fixation Nailing System TDM Anterior Cervical Plate System Plate Cutter TDM Plate and Screw Systems Fixator Driver Flexible Reamer Shaft for Humerus Nail Reamer for 1st MTP Start Reamer for PHN Start Reamer for Humerus Nail TDM Plate and screw system Trifix plate and screw system Cannulated Driver for Compression Screw Lag Sleeve Remove Driver Assemble Driver Remove Driver Flexible Screw Driver Lag Screw Driver for CHN Flow Lag Screw Driver, H-Type Screw Driver Shaft, Holding Screw Driver, Holding Crane Screw Driver(PCS-301) Cannulated Screw Driver,Star Lag Screw Driver Outer for CHN, 10mm Sliding Crane Screw Driver(PCS-302) Lag Screw Remove Driver Screw Driver, Star Screw Removal Driver Shaft Reduction Guide Drill Sleeve for Tibia Variable Locking Drill Guide Coupling Screw Extract Bolt for Universal Locking Drill Sleeve, Single Handle, for Small Head Fixator Driver with Silicon Handle Pin Guide Protection Sleeve for Tibia Drilling Block, Small Assemble Bolt Lock Screw 3.5 Wedge Inserter Spreader Flow Lag Screw Pusher Drill Sleeve for Guide Pin Alignment Tube Free Hand Drill Sleeve 4.3 Locking Drill Guide for 3.5 Variable Locker Variable Drill Guide Variable Drill Guide, Single Handle Protection Sleeve for HIN Distal Drill Sleeve for HIN Distal Pectus Crane Screw(PSF-908, PSF-910, PSF-912, PSF-914, PSF-916) Modified Filpper(PPM-015) Bottom Post(PPM-102) Parallel Drill Guide Torque Limit Handle MIFix Perio(919-10000) Drilling Block, DRLP, Intra Articular, Small Screw Driver Shaft Table Top Bender(PMI-020) Cannulated Screw Driver Drilling Block, Fibular, Lateral Plate Hodling Sleeve (Solid) Drilling Block, DRLP, Intra Articular Temporary Fixation K-wire Guide Wire Cannulated Screw Driver Shaft Bar Positioning Hook(PMI-053) Modified Clamp(PPM-013) Drilling Block, PHLP Pectus Crane Screw(PSF-1208, PSF-1210, PSF-1212, PSF-1214, PSF-1216) Cannulated Quick Chuck Drilling Block, Fibular, Posterior Rod Introducer (PPM-123) Cannulated Depth Gauge MIFix Cannular Handle(904004-1001) Crane Elevator(PPM-106) MIFix Double sleeve handle(904005-1220, 904005-1425) Fixator Container(PPM-019) Broken Hexa Remove Driver Shaft Flare Buster Tunneler(PMI-072) Cannulated Tap with T-Handle Assemble Handle for Femur Coupling Screw for End Cap Driver, Flexible Holding Screw With Cutting Guide Trocar for Tibia Easy Crane System(PPM-100) Fixator Driver(PPM-010) Handheld Bar Bender(PMI-021) Extract Bolt with Tip Trocar for Free Hand Coupling Screw for Flow Lag Screw Pectus Crane Screw(PSF-1008, PSF-1010, PSF-1012, PSF-1014, PSF-1016) Template Bar(PPE-210TP, PPE-212TP, PPE-214TP, PPE-216TP) Protective Cutting System Rod Pusher Drilling Block, PTL Trocar for Femur Assemble Bolt for Retrograde Alignment Tube for Humerus Nail Cutting Guide Drilling Block, Distal Tibia, Posterior Assemble Handle Protection Sleeve Pre-Load Drill Guide Protection Sleeve for Lag Screw Cutting Block Universal Chuck With T- Handle Drilling Block, Large Drilling Block, Medium Drilling Block, DFL Lock Screw 2.7 Assemble Bolt Driver For CHN Guide Pin Holder Locking Drill Sleeve, Single Handle Assemble Bolt For CHN MIFix Cannular Driver Shaft(904004-0008, 904004-0010) Handle Bar Extract Bolt Driver for Variable Locking Drill Guide Parallel Pin Guide Trocar for Start Reamer Protection Sleeve for Femur Extract Bolt for CHN Reamer Guide for 1st MTP Driver for Variable Drill Guide Guide wire, Non-Threaded Countersink with Measuring Device T-Handle MIFix Guide Pin Trocar Type(904001-0011, 904001-0013) Trocar for Recon Quick Chuck Small T-Handle Rotation Pin Guide Protection Sleeve for Recon Proximal Target Device 130 Free Hand Drill Guide Insert Pin Guide Pectus Crane Screw(PSF-1108, PSF-1110, PSF-1112, PSF-1114, PSF-1116) Plate Positioning Pin Wrench End Cap Driver Hercules Bar Removal Bender(PPM-012) Target Guide for Retrograde, A/P Reaming Rod Pusher Pin Guide 3.5 Compression Driver for TIN Assemble Handle for Tibia Assemble Bolt Driver Holding Screw With Cutting Block Protection Sleeve for Distal Assemble/Extract Bolt Cannulated Quick Chuck Small Cannulated Tap Impact Cap Drill Sleeve, Single Handle Pin Guide 2 Drill Sleeve for Distal Assemble/Extract Bolt With Tip Compression Sleeve Drill Sleeve Proximal Target Device for Femur Fixator Clip Applier(PPM-011) Bar Introducer Small(PMI-022) Pectus Crane Screw(PSF-3208, PSF-3210, PSF-3212, PSF-3214, PSF-3216) MIFix Guide Pin Dispenser(904011-0011, 904011-0013) Supporting Bar(PPM-104) Quick Chuck T-Handle Impact Handle Slotted Mallet Compression Driver for FIN Drilling Block, Distal Injection Pusher Flare Buster Compressor(PPM-200) DCP Drill Guide Drilling Block, DTM Protection Sleeve_Calcar Hole Target Device for Tibia, Lateral Extract Rod for Ram Introduce Director (PPM-124) Bone Hook Plate Positioning Screw Drilling Block, Distal Fibular Spoon/Hole Bar Introducer Large(PMI-023) Proximal Target Device 125 Extract Hook Screw Driver Shaft, Star Pectus Crane Screw(PSF-4208, PSF-4210, PSF-4212, PSF-4214, PSF-4216) Fixator Clip Applier with Silicon Handle Drilling Block, Distal Tibia, Anterior Drilling Block, PTM Impact Handle for Retrograde Assemble Handle with Shaft for CHN Container Box(PPM-018) Extract Bolt without Handle Locking Drill Guide for 2.7 Variable Trocar Ram Mallet Broken Hexa Remove Driver with T-Handle End Cap Driver, Flexible I-Handle Coupling Screw for End Cap Driver Drilling Block, DTL Target Guide for Rertograde Target Device Locking Drill Sleeve Pin Guide 4 Quick Coupling Handle for Small Drilling Block, TOPFIX Assemble/Extract Rod Coupling Screw for CHN Double Drill Sleeve Slotted Hammer for Humerus Proximal Target Device for Tibia Quick Coupling Handle for Large Drill Guide for PHN Guide Pin Dispenser Free Hand Drill Sleeve 3.5 Plate Holding Sleeve, Solid Skin Protecter Drill Sleeve for Recon Universal Drill Guide End Cap Driver, Rigid Drill Sleeve for Femur Awl with T-Handle Bone Awl 10mm Primary Awl for TIN Cannulated Curved Awl Primary Awl Bone Awl, 5mm 7.5mm Limited Sliding Locking Screw, Short(775001-2070~2110) MIFix Cannulated Screw 3.5mm(793501-1022~1064) MIFix Cannulated Screw 3mm(793001-1020~1050) 7.5mm Limited Sliding Locking Screw, Long(775101-2070~2110) TDM Screw System Compressing Plate(PPM-206) Bottom Post(PPM-202) Carinatum Hook Bar Puller(PPM-208) Supporting Cross Bar(PPM-204) Flare Compressor(PPM-200) Holding Forcep Compression Forcep Osteotome Extractor(Osteotome) Cannulated Step Drill Cannulated Tap for 6.5mm Cannulated Step drill for CHN Drill Bit Lag Screw Tap Cannulated Tap for 4mm Cannulated Drill Bit Drill Bit, AO Chuck MIFix Cannular Drill Bit (904002-0019, 904002-0024) Cannulated Countersink for 4mm Step Drill for Recon Cannulated Step Drill Stopper Cannulated Countersink for 6.5mm TDM Large Bone Plate and Screw System TDM Lumbar Interbody Fusion Cage System MIFix Burr (904111-2008, 904111-2012, 904111-2022, 904111-2222, 904111-2913, 904111-3012, 904111-3030, 904111-4313) Guide Pin Guide Pin for entry/antirotation Guide Pin for CHN Lag Screw TDM Screw Systems Park's Pectus System PINE Pedicle Screw System

Establishment Types

Manufacture Medical Device