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Data / Medical devices / Taiwan / Microware Precision Co., Ltd.

Microware Precision Co., Ltd.: FDA-registered device maker in Taichung, Taiwan, 7 510(k) clearances

Microware Precision Co., Ltd. is registered with the FDA (registration 3007738812) in Taichung, Taiwan. It lists 24 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 14, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Microware Precision Co., Ltd.
FDA registration number
3007738812
Address
No. 12, Keyuan 2nd Rd., Situn District, Taichung, Taiwan, 407736
Owner or operator
Microware Precision Co., Ltd. (10028733)
Roles
Contract manufacturer, Manufacturer
First device listed
March 2, 2009
Registered through
2026
Brand names listed
0.7mm Guide Wire, 0.8mm Guide wire, for 2.4mm Cannulated Screw, 1.6mm Guide Wire, for 4.5mm cannulated Screw, 1.7mm Cannulated Drill Bit, for 2.4mm Cannulated Screw, 12.5mm Tap, 135 Degree Angle Guide, 140 Degree Angle Guide, 145 Degree Angle Guide and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract manufacturer, Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeLXT2Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufacturer, Manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Contract manufacturer, Manufactureraccessdata.fda.gov
Cover, Burr HoleGXR2Contract manufactureraccessdata.fda.gov
Fastener, Plate, CranioplastyHBW2Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Contract manufacturer, Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Contract manufactureraccessdata.fda.gov
Plate, BoneJEY2Contract manufacturer, Manufactureraccessdata.fda.gov
Plate, Cranioplasty, Preformed, AlterableGWO2Contract manufactureraccessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-AlterableGXN2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Manufactureraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
Screw, Fixation, IntraosseousDZL2Contract manufacturer, Manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufactureraccessdata.fda.gov
Washer, Bolt, Nut, Non-Spinal, MetallicNDG2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 14, 2024K242814Tandry Q-Locking Plate SystemHRSSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov
August 17, 2023K230690Tandry Locking Plate SystemHRSSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov
November 10, 2022K220360Tandry CMF Plate SystemJEYSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov
September 20, 2022K220359Tandry Compression Screw SystemHWCSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov
November 6, 2019K182929BIO-RAY A-1 Anchor Screw SystemOATSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov
May 2, 2012K111008MICROWARE BONE PLATES AND BONE SCREWHRSSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov
December 4, 2008K072562MICROWARE BONE PLATES AND BONE SCREWSHRSSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 14, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.