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Data / Medical devices / Taiwan / Intai Technology Corp. Implants Business Unit

Intai Technology Corp. Implants Business Unit: FDA-registered device maker in Taichung City, Taiwan, 3 510(k) clearances

Intai Technology Corp. Implants Business Unit is registered with the FDA (registration 3011187779) in Taichung City, Taiwan. It lists 26 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 11, 2022. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Intai Technology Corp. Implants Business Unit
FDA registration number
3011187779
Address
No.9 Jingke Road, Nantun District, Taichung City, Taiwan, 40852
Owner or operator
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT (10046565)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer
First device listed
April 8, 2014
Registered through
2027
Brand names listed
1.5 Lance Drill, 1.8 Guide Drill, 1.8 Lance Drill, 10 mmL 2-4 short Drill Stopper, 10 mmL 4-5 short Drill Stopper, 2 10 Twist Drill, 2 11.5 Twist Drill, 2 13 Twist Drill and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Contract manufacturer, Manufactureraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Orthopedic TrayOJH1Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
WrenchHXC1Contract 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
March 11, 2022K201229Intai Anatomic Locking Plate and Screw SystemHRSSubstantially EquivalentIntai Technology Corporationaccessdata.fda.gov
May 20, 2013K122804ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDZESubstantially EquivalentIntai Technology Corp.accessdata.fda.gov
December 14, 2006K063020INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEMHRSSubstantially EquivalentIntai Technology, Inc.accessdata.fda.gov

Compare with other makers

Updated March 11, 2022. 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.