Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014257776

FEI Number

3014257776

Entity Name

TDM CO.,LTD

City/State/Country

Gwangju, KR

Establishment Address

69, Cheomdan Venture so-ro 37beon-gil, Gwangju 61003, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TDM Co.,Ltd (Owner Number: 10057351)

Owner / Operator Contact Address

69, Cheomdan Venture so-ro 37beon-gil, Gwangju, KR-29 61003, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221844

PMA Number

N/A

All Registered 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 Plate and Screw Systems TDM Lumbar Interbody Fusion Cage System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2020-05-06
HXW	Bender	Orthopedic	Class 1	888.4540	2018-05-13
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-05-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-08-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-04-25
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2019-11-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-11-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-11-19
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-05-06
HTO	Reamer	Orthopedic	Class 1	888.4540	2018-05-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-03-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-03-25
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-05-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-05-21
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2018-04-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-01-29
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2022-10-12
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-11-07
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2025-05-15
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2018-05-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-04-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-01-29

Official Correspondent

JungWook Choi

US Agent Details

Pia Kim Business: TDM USA Inc. Email: mj2334@tdmkorea.com Phone: (347) 5232334

Related Public Records

Same Entity

TDM Co.,Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014257776. Last updated year: 2026. Please use registration number 3014257776 when referencing this establishment in official correspondence.