FDA Registration
Active
🇰🇷 South Korea
Fixator Container(PPM-019)
Reg #: 3014257776
·
FEI: 3014257776
·
Expires 2025
Products
1
Proprietary Names
186
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TDM CO.,LTD
- Registration Number
- 3014257776
- FEI Number
- 3014257776
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 69, Cheomdan Venture so-ro 37beon-gil
- City
- Gwangju
- Country
- KR
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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-05-21 |
Proprietary Names
Fixator Container(PPM-019)
Assemble Bolt
Screw Driver Shaft, Star
Protection Sleeve for Lag Screw
Drilling Block, DTM
Plate Positioning Screw
Assemble Handle for Femur
Coupling Screw for End Cap Driver, Flexible
Drill Sleeve for Distal
Pre-Load Drill Guide
Alignment Tube
Trocar for Free Hand
Locking Drill Guide for 3.5 Variable
Drilling Block, PTL
Alignment Tube for Humerus Nail
Flow Lag Screw Pusher
Assemble Handle
Protection Sleeve
Drill Guide for PHN
Assemble Bolt For CHN
Free Hand Drill Sleeve 3.5
Trocar for Femur
Plate Positioning Pin
Compression Driver for FIN
Cannulated Tap
Reamer Guide for 1st MTP
Drill Sleeve, Single Handle
Extract Hook
Protection Sleeve for Tibia
Trocar for Tibia
Assemble Handle with Shaft for CHN
Extract Bolt for CHN
Free Hand Drill Guide
Drill Sleeve for Femur
Extract Bolt without Handle
Broken Hexa Remove Driver with T-Handle
End Cap Driver, Flexible
Reaming Rod Pusher
Handle Bar
Trocar
Impact Handle
Impact Cap
Proximal Target Device 125
Skin Protecter
Variable Drill Guide
Drill Sleeve for Recon
Assemble Bolt Driver
Coupling Screw for CHN
Variable Drill Guide, Single Handle
Assemble/Extract Bolt With Tip
Reduction Guide
Cutting Guide
Spreader
Quick Coupling Handle for Small
Extract Bolt for Universal
Target Guide for Retrograde, A/P
Locking Drill Sleeve, Single Handle
Drill Sleeve
Proximal Target Device 130
Locker
Cannulated Depth Gauge
Plate Hodling Sleeve (Solid)
MIFix Cannular Driver Shaft(904004-0008, 904004-0010)
Handheld Bar Bender(PMI-021)
Parallel Drill Guide
Bar Introducer Large(PMI-023)
Rod Introducer (PPM-123)
Cannulated Quick Chuck
Guide wire, Non-Threaded
Cannulated Tap with T-Handle
MIFix Cannular Handle(904004-1001)
Template Bar(PPE-210TP, PPE-212TP, PPE-214TP, PPE-216TP)
Cannulated Screw Driver
Hercules Bar Removal Bender(PPM-012)
Drilling Block, DRLP, Intra Articular
Drilling Block, Distal Fibular Spoon/Hole
Cannulated Screw Driver Shaft
Bottom Post(PPM-102)
Fixator Clip Applier(PPM-011)
Countersink with Measuring Device T-Handle
MIFix Guide Pin Trocar Type(904001-0011, 904001-0013)
Drilling Block, Distal Tibia, Anterior
MIFix Double sleeve handle(904005-1220, 904005-1425)
Torque Limit Handle
MIFix Perio(919-10000)
Drilling Block, Distal Tibia, Posterior
Guide Wire
Drilling Block, Fibular, Posterior
Drilling Block, Fibular, Lateral
Pectus Crane Screw(PSF-1008, PSF-1010, PSF-1012, PSF-1014, PSF-1016)
Flare Buster Compressor(PPM-200)
DCP Drill Guide
Easy Crane System(PPM-100)
Fixator Driver(PPM-010)
Drilling Block, DRLP, Intra Articular, Small
Container Box(PPM-018)
Trocar for Recon
Drilling Block, Medium
Drilling Block, Small
Rod Pusher
Extract Bolt with Tip
Cannulated Quick Chuck Small
Drilling Block, TOPFIX
Quick Chuck Small T-Handle
Rotation Pin Guide
I-Handle
Coupling Screw for End Cap Driver
Protective Cutting System
Drilling Block, DFL
Plate Holding Sleeve, Solid
Holding Screw With Cutting Block
Quick Coupling Handle for Large
Guide Pin Dispenser
Ram Mallet
End Cap Driver
Target Device
Injection Pusher
Pin Guide 4
Protection Sleeve for Distal
Universal Drill Guide
Compression Sleeve
Locking Drill Guide for 2.7 Variable
Proximal Target Device for Femur
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)
MIFix Guide Pin Dispenser(904011-0011, 904011-0013)
Lock Screw 3.5
Holding Screw With Cutting Guide
End Cap Driver, Rigid
Assemble/Extract Rod
Double Drill Sleeve
Impact Handle for Retrograde
Protection Sleeve for Recon
Drilling Block, Large
Cutting Block
Free Hand Drill Sleeve 4.3
Wedge Inserter
Wrench
Assemble Handle for Tibia
Drilling Block, DTL
Assemble Bolt for Retrograde
Drill Sleeve for Tibia
Target Guide for Rertograde
Locking Drill Sleeve
Screw Driver Shaft
Drilling Block, Distal
Parallel Pin Guide
Drill Sleeve for Guide Pin
Protection Sleeve for Femur
Compression Driver for TIN
Extract Bolt
Coupling Screw for Flow Lag Screw
Driver for Variable Drill Guide
Assemble/Extract Bolt
Guide Pin Holder
Pin Guide 3.5
Extract Rod for Ram
Pectus Crane Screw(PSF-4208, PSF-4210, PSF-4212, PSF-4214, PSF-4216)
Lock Screw 2.7
Flare Buster Tunneler(PMI-072)
Drilling Block, PHLP
Bar Introducer Small(PMI-022)
Drilling Block, PTM
Insert Pin Guide
Pectus Crane Screw(PSF-1108, PSF-1110, PSF-1112, PSF-1114, PSF-1116)
Introduce Director (PPM-124)
Bone Hook
Temporary Fixation K-wire
Crane Elevator(PPM-106)
Pin Guide
Slotted Hammer for Humerus
Proximal Target Device for Tibia
Table Top Bender(PMI-020)
Pectus Crane Screw(PSF-908, PSF-910, PSF-912, PSF-914, PSF-916)
Modified Filpper(PPM-015)
Bar Positioning Hook(PMI-053)
Modified Clamp(PPM-013)
Coupling Screw
Protection Sleeve_Calcar Hole
Locking Drill Sleeve, Single Handle, for Small Head
Target Device for Tibia, Lateral
Trocar for Start Reamer
Assemble Bolt Driver For CHN
Broken Hexa Remove Driver Shaft
Supporting Bar(PPM-104)
Quick Chuck T-Handle
Establishment Types
Manufacture Medical Device