Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007738812

FEI Number

3007738812

Entity Name

MICROWARE PRECISION CO., LTD.

City/State/Country

Taichung, TW

Establishment Address

No. 12, Keyuan 2nd Rd., Situn District,, Taichung 407736, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Microware Precision Co., Ltd. (Owner Number: 10028733)

Owner / Operator Contact Address

No. 12, Keyuan 2nd Rd., Situn District,, Taichung, TW-TXG 407736, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Ortholock Screw Microware Bone Plates and Bone Screws Drill guide, various types of drill guides BIOMET MICROFIXATION NEURO PLATING SYSTEM BIO-RAY A-1 Anchor Screw System Tandry Compression Screw System Tandry CMF Plate System SPIN DOWN RAPIDFLAP BUR, SURGICAL, GENERAL & PLASTIC SURGERY Tandry Q-Locking Plate System 3.2mm Cannulated Drill Bit, for 4.5mm Cannulated Screw 0.7mm Guide Wire 1.6mm Guide Wire, for 4.5mm cannulated Screw 0.8mm Guide wire, for 2.4mm Cannulated Screw 1.7mm Cannulated Drill Bit, for 2.4mm Cannulated Screw Drill Bit, 5/2.9mm, Cannulated, 7.3mm Cannulated Screw Guide Wire, 2.5mm dia., with threaded tip, length 230mm Guide Wire, 2.8mm dia., with spade point, length 300mm Drill Bit, 2.7/1.35mm, Cannulated Guide Wire. 1.25mm, with Thread Tip, Length 150mm various types of drill OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM Tandry Locking Plate System FlexFix Syndesmosis Repair Kit Screwdriver Shaft T8, Cannulated, for Cannulated Screw 2.4mm Screwdriver Shaft, Hexagonal, Cannulated Screw 6.5/7.3mm Countersink, Cannulated, for Cannulated Screw 2.4mm Measuring Device, for Cannulated Screw 2.4mm Double Drill Sleeve 1.7/0.8mm, for Cannulated Screw 2.4mm 2.4mm Cannulated Screws and Instruments Case Screw Forceps, for Cannulated Screw 2.4mm 7.3 CANNULATED SCREW AND INSTRUMENT SET Screwdriver Shaft, Hexagonal, 7.3mm Cannulated Screw Screwdriver, Hexagonal, 7.3mm Cannulated Screw Tap, Cannulated, 7.3mm Cannulated Screw Protection Sleeve 12/8.5mm, 7.3mm Cannulated Screw 135 Degree Angle Guide Impactor Tip Small T-Handle Screw Caddy, Cannulated Screw 7.3mm, Fully Threaded Screw Caddy, Cannulated Screw 7.3mm, Thread Length 32mm Drill Sleeve, 8.5/2.8mm, 7.3mm Cannulated Screw Screw Forceps, Self-rataining Protection Sleeve, 15.5/13mm, 7.3mm Cannulated Screw 145 Degree Angle Guide Triple Reamer Drill Bit Shaft 3.5mm Wood Handle Screwdriver Screw Caddy, Cannulated Screw 7.3mm, Thread Length 16mm Centering Sleeve for Tap Measuring Device, 300mm, 7.3mm Cannulated Screw Paraell Wire Guide, 2.8mm Adjustable, 7.3mm Cannulated Screw Instrument Tray, 7.3mm Cannulated Screw and Instrument Trocar, 2.8mm,7.3mm Cannulated Screw Countersink, Cannulated, 7.3mm Cannulated screw Short Reamer Head Guide shaft with Flats Centering Sleeve for Lag Screw Wrench Direct Measuring Device Outside Case, 7.3mm Cannulated Screw and Instrument Standard Reamer Head SHS Impactor Shaft Lag Screw Retaining Rod (For Removal) Hip Screw T-Handle Lag Screw Insertion Wrench Triple Reamer Locking Nut Large Fragment Depth Gauge Hip Screw Drill Guide 12.5mm Tap Lag Screw Retaining Rod (For Insertion) 3.5mm Hexdriver Shaft (Short) 140 Degree Angle Guide Double Drill Guide 2.7/1.25mm Screwdriver Shaft, Cannulated, for Cannulated Screw 4mm HPS Screws and Instruments Case 4mm Cannulate Screws and Instruments Case Handle with Quick Coupling HPS Lag Screws and Plates Case Tap, Cannulated, for Cannulated Screw 4mm Screwdriver, Cannulated, for Cannulated Screw 4mm Countersink, for Cannulated screw 4mm 4.5mm Tap Direct Measuring Device, for Cannulated Screw 4mm Manual surgical instrument; various types of manual Screwdriver Shaft T8, for Cannulated Screw 2.4mm Biomet Microfixation OmniMax MMF System MRI Vision Bolt Variable Tensioned Wire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2026-03-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-05-22
NDG	Washer, Bolt, Nut, Non-Spinal, Metallic	Orthopedic	Class 2	888.3030	2012-05-22
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-05-22
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-05-07
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2018-09-24
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2018-09-24
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2018-09-24
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2024-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-22
JEY	Plate, Bone	Dental	Class 2	872.4760	2024-05-23
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2024-05-23
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2019-02-14
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2024-11-18
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-03-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-06-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-06-02
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-06-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-06-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2011-01-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-09-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-09-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-05-22
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-08-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-03-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2010-12-08
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2018-09-20
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-09-20
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-03-03
HWT	Template	Orthopedic	Class 1	888.4800	2016-09-08

Official Correspondent

Harrison Du

US Agent Details

Honggi Chuang Email: joshzngf@gmail.com Phone: (650) 4959052

Related Public Records

Same Entity

Microware Precision 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
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007738812. Last updated year: 2026. Please use registration number 3007738812 when referencing this establishment in official correspondence.