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
- [email protected]
- Phone
- 347 5232334
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2020-05-06 |
| Bender | HXW | Class 1 | Orthopedic | No | 2018-05-13 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-05-13 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-08-27 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-04-25 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2019-11-07 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-11-19 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-11-19 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2020-05-06 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2018-05-13 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-05-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-05-21 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2018-04-05 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2022-10-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-11-07 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2025-05-15 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-05-13 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-01-29 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2024-01-30 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2020-05-06 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2025-04-09 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-10-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-09-05 |
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