FDA Registration
Active
🇺🇸 United States
Introduce Director (PPM-124)
Reg #: 3031261833
·
FEI: 3031261833
·
Expires 2025
Products
1
Proprietary Names
63
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TDM USA INC.
- Registration Number
- 3031261833
- FEI Number
- 3031261833
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4020 215th Street
- City
- Bayside
- State
- NY
- ZIP
- 11361
- Country
- US
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-06-04 |
Proprietary Names
Introduce Director (PPM-124)
Easy Crane System(PPM-100)
Drilling Block, DRLP, Intra Articular, Small
Pectus Crane Screw(PSF-4208, PSF-4210, PSF-4212, PSF-4214, PSF-4216)
Rod Introducer (PPM-123)
Guide Wire
Locking Drill Sleeve
Drilling Block, DRLP, Intra Articular
Cannulated Tap with T-Handle
Torque Limit Handle
Bar Introducer Small(PMI-022)
Flare Buster Tunneler(PMI-072)
Pectus Crane Screw(PSF-1208, PSF-1210, PSF-1212, PSF-1214, PSF-1216)
Drilling Block, PHLP
Hercules Bar Removal Bender(PPM-012)
Drilling Block, Fibular, Lateral
Supporting Bar(PPM-104)
MIFix Guide Pin Trocar Type(904001-0011, 904001-0013)
Countersink with Measuring Device T-Handle
Cannulated Quick Chuck
Modified Clamp(PPM-013)
Locking Drill Sleeve, for Small Head
Drilling Block, Distal Tibia, Anterior
MIFix Guide Pin Dispenser(904011-0011, 904011-0013)
MIFix Cannular Driver Shaft(904004-0008, 904004-0010)
Cannulated Screw Driver Shaft
Plate Hodling Sleeve (Solid)
MIFix Double sleeve handle(904005-1220, 904005-1425)
Drilling Block, Distal Fibular Spoon/Hole
Pectus Crane Screw(PSF-1108, PSF-1110, PSF-1112, PSF-1114, PSF-1116)
Drilling Block, Distal
MIFix Cannular Handle(904004-1001)
Crane Elevator(PPM-106)
Temporary Fixation K-wire
Screw Driver Shaft
Quick Chuck T-Handle
Locking Drill Sleeve, Single Handle, for Small Head
Bar Positioning Hook(PMI-053)
Insert Pin Guide
Handheld Bar Bender(PMI-021)
Drilling Block, Distal Tibia, Posterior
Cannulated Screw Driver
MIFix Perio(919-10000)
Table Top Bender(PMI-020)
Locking Drill Sleeve, Single Handle
Parallel Drill Guide
Fixator Driver(PPM-010)
Drill Sleeve, Single Handle
Flare Buster Compressor
Drilling Block, Fibular, Posterior
Fixator Clip Applier(PPM-011)
Cannulated Depth Gauge
DCP Drill Guide
Pectus Crane Screw(PSF-3208, PSF-3210, PSF-3212, PSF-3214, PSF-3216)
Bone Hook
Guide wire, Non-Threaded
Template Bar(PPM-210TP, PPM-212TP, PPM-214TP, PPM-216TP)
Broken Hexa Remove Driver Shaft
Bar Introducer Large(PMI-023)
Modified Filpper(PPM-015)
Pectus Crane Screw(PSF-1008, PSF-1010, PSF-1012, PSF-1014, PSF-1016)
Bottom Post(PPM-102)
Pectus Crane Screw(PSF-908, PSF-910, PSF-912, PSF-914, PSF-916)
Establishment Types
Repack or Relabel Medical Device