Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031261833

FEI Number

3031261833

Entity Name

TDM USA INC.

City/State/Country

Bayside, NY, US

Establishment Address

4020 215th Street, Bayside, NY 11361, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

TDM USA INC. (Owner Number: 10090919)

Owner / Operator Contact Address

4020 215th Street, Bayside, NY 11361, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191057

PMA Number

N/A

All Registered Proprietary Names

Trifix plate and screw system TDM Plate and screw system TDM Intramedullary Fixation Nailing System MIFix Depth Gauge (904003-0001) Depth Gauge Pate Bending Piler, Flat Bender Bender, Small TDM Screw Systems Fixator Clip Applier TDM Plate and Screw Systems Plate Cutter TDM Anterior Cervical Plate System Reamer for 1st MTP Reamer Guide for 1st MTP PINE Pedicle Screw System TDM Large Bone Plate and Screw System Bone Hook Fixator Driver MIFix Cannular Drill Bit (904002-0019, 904002-0024) Drill Bit Cannulated Drill Bit Drill Bit, AO Chuck Bone Awl 10mm Bone Awl, 5mm Easy Crane System(PPM-100) Introduce Director (PPM-124) Screw Driver Shaft MIFix Guide Pin Trocar Type(904001-0011, 904001-0013) Supporting Bar(PPM-104) MIFix Guide Pin Dispenser(904011-0011, 904011-0013) Template Bar(PPM-210TP, PPM-212TP, PPM-214TP, PPM-216TP) Locking Drill Sleeve, Single Handle, for Small Head Insert Pin Guide Drilling Block, Distal Fibular Spoon/Hole Locking Drill Sleeve Drilling Block, DRLP, Intra Articular Bottom Post(PPM-102) Table Top Bender(PMI-020) Locking Drill Sleeve, Single Handle Quick Chuck T-Handle Torque Limit Handle Bar Introducer Small(PMI-022) MIFix Perio(919-10000) MIFix Double sleeve handle(904005-1220, 904005-1425) Drilling Block, DRLP, Intra Articular, Small Flare Buster Tunneler(PMI-072) 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) Broken Hexa Remove Driver Shaft Bar Introducer Large(PMI-023) Bar Positioning Hook(PMI-053) Drilling Block, Fibular, Posterior Temporary Fixation K-wire Cannulated Quick Chuck Drill Sleeve, Single Handle Cannulated Tap with T-Handle Parallel Drill Guide Handheld Bar Bender(PMI-021) Drilling Block, Distal Tibia, Posterior MIFix Cannular Handle(904004-1001) Countersink with Measuring Device T-Handle Pectus Crane Screw(PSF-908, PSF-910, PSF-912, PSF-914, PSF-916) Fixator Clip Applier(PPM-011) Cannulated Depth Gauge DCP Drill Guide Cannulated Screw Driver Drilling Block, PHLP Fixator Driver(PPM-010) Rod Introducer (PPM-123) Drilling Block, Distal Tibia, Anterior Pectus Crane Screw(PSF-1108, PSF-1110, PSF-1112, PSF-1114, PSF-1116) Guide wire, Non-Threaded Flare Buster Compressor Pectus Crane Screw(PSF-1008, PSF-1010, PSF-1012, PSF-1014, PSF-1016) Drilling Block, Distal Modified Clamp(PPM-013) MIFix Cannular Driver Shaft(904004-0008, 904004-0010) Crane Elevator(PPM-106) Guide Wire Bone Hook Hercules Bar Removal Bender(PPM-012) Drilling Block, Fibular, Lateral Cannulated Screw Driver Shaft Plate Hodling Sleeve (Solid) Pectus Crane Screw(PSF-4208, PSF-4210, PSF-4212, PSF-4214, PSF-4216) Locking Drill Sleeve, for Small Head Modified Filpper(PPM-015) Park's Pectus System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-09-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2024-06-04
HXW	Bender	Orthopedic	Class 1	888.4540	2024-06-04
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-06-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-02
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2024-06-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-02
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2024-06-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-06-02
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-06-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-06-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-02
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2024-06-04
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-06-04
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2024-06-04
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2024-06-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-06-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-02

Official Correspondent

Minjeong Kim-Jin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TDM USA INC.

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031261833. Last updated year: 2026. Please use registration number 3031261833 when referencing this establishment in official correspondence.