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Data / Medical devices / Taiwan / Syntec Scientific Corp.

Syntec Scientific Corp.: FDA-registered device maker in CHANG HUA Changhua, Taiwan, 10 510(k) clearances

Syntec Scientific Corp. is registered with the FDA (registration 9616944) in CHANG HUA Changhua, Taiwan. It lists 44 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 28, 2020. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Syntec Scientific Corp.
FDA registration number
9616944
FEI number
3003414678
Address
2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, CHANG HUA Changhua, Taiwan, 509
Owner or operator
Syntec Scientific Corporation (9034982)
Roles
Contract manufacturer, Manufacturer
First device listed
March 19, 2009
Registered through
2026
Brand names listed
01-1005-0008 Cannulated Countersink2.4/6, 01-1006-0001 SPICA TABLE ASSEMBLY, 03-1006-0104 .25" SPICA SEAT, SPICA TABLE, 03-1006-0400 SPICA ARM-BAR, SPICA TABLE, 03-1006-0401 SPICA TABLE ARM BAR, DOUBLE WIDTH, 09-1010-010 DOUBLE DRILL GUIDE 3.2/1.60 MM, 1.5 CONDYLAR PLT, RIGHT, 1.5 H-PLT, 4 HOLE and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract manufactureraccessdata.fda.gov
BenderHXW1Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufacturer, Manufactureraccessdata.fda.gov
Bit, SurgicalGFG1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Contract manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Contract manufactureraccessdata.fda.gov
ForcepsHTD1Contract manufacturer, Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufacturer, Manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Contract manufacturer, Manufactureraccessdata.fda.gov
Nail, Fixation, BoneJDS2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Contract manufacturer, Manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Contract manufacturer, Manufactureraccessdata.fda.gov
Plate, Bone, Growth Control, Pediatric, EpiphysiodesisOBT2Contract manufacturer, Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedPAO2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedMBF2Contract manufactureraccessdata.fda.gov
ReamerHTO1Contract manufactureraccessdata.fda.gov
RetractorGAD1Contract manufacturer, Manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Contract manufacturer, Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufacturer, Manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract manufactureraccessdata.fda.gov
Table, Surgical With Orthopedic Accessories, ManualJEB1Contract manufacturer, Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract 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
October 28, 2020K202935Syntec Femoral Nail Extended SystemHSBSubstantially EquivalentSyntec Scientific Corporationaccessdata.fda.gov
April 11, 2019K181296Syntec Femoral Nail SystemHSBSubstantially EquivalentSyntec Scientific Corporationaccessdata.fda.gov
June 8, 2017K161327SYNTEC HUMERAL NAIL SYSTEMHSBSubstantially EquivalentSyntec Scientific Corporationaccessdata.fda.gov
March 25, 2011K101971SYNTEC OS SPINAL FIXATION SYSTEMNKBSubstantially EquivalentSyntec Scientific Corp.accessdata.fda.gov
June 25, 2010K092889SYNTEC OSTEO-PLATE AND SCREW FIXATIONHRSSubstantially EquivalentSyntec Scientific Corp.accessdata.fda.gov
May 17, 2010K100240ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEMHRSSubstantially EquivalentOrthoPediatrics Corp.accessdata.fda.gov
April 24, 2009K090839MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTSHRSSubstantially EquivalentSyntec Scientific Corp.accessdata.fda.gov
April 24, 2009K090666PEDIPLATESHRSSubstantially EquivalentOrthoPediatrics Corp.accessdata.fda.gov
October 17, 2008K082375ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTYSubstantially EquivalentOrthoPediatrics Corp.accessdata.fda.gov
December 16, 1998K983495SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420HWCSubstantially EquivalentSyntec Scientific Corp.accessdata.fda.gov

Compare with other makers

Updated October 28, 2020. 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.