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Data / Medical devices / China / Shandong Weigao Orthopaedic Device Co.,ltd

Shandong Weigao Orthopaedic Device Co.,ltd: FDA-registered device maker in weihai Shandong, China, 7 510(k) clearances

Shandong Weigao Orthopaedic Device Co.,ltd is registered with the FDA (registration 3006639944) in weihai Shandong, China. It lists 42 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 4, 2017. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Shandong Weigao Orthopaedic Device Co.,ltd
FDA registration number
3006639944
Address
No 26 Xiangjiang Road,Tourist Resorts, weihai Shandong, China, 264203
Owner or operator
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD (10024709)
Roles
Contract manufacturer, Manufacturer
First device listed
February 19, 2008
Registered through
2026
Brand names listed
APPLIANCE, FIXATION, SPINAL INTERLAMINAL, AWL, Accessories, arthroscopic, Appliance, fixation, spinal intervertebral body, BROACH, Dissector, Surgical, General & Plastic Surgery, General Spinal System, Guide, surgical, instrument and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufacturer, Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufacturer, Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufacturer, Manufactureraccessdata.fda.gov
AwlHWJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Contract manufactureraccessdata.fda.gov
Bone Fixation Cerclage, SublaminarOWI2Contract manufactureraccessdata.fda.gov
BroachHTQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Contract manufactureraccessdata.fda.gov
Electromyograph, DiagnosticIKN2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Contract manufacturer, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufacturer, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Light, Surgical, CarrierFSZ2Contract manufactureraccessdata.fda.gov
Light, Surgical, FiberopticFST2Contract manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Contract manufactureraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufacturer, Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufacturer, Manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
Posterior Metal/Polymer Spinal System, FusionNQP2Contract manufactureraccessdata.fda.gov
ProbeHXB1Contract manufacturer, Manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufacturer, Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Contract manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Evoked ResponseGWF2Contract manufactureraccessdata.fda.gov
Stimulator, NerveETN2Contract manufactureraccessdata.fda.gov
TampHXG1Contract manufacturer, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufacturer, Manufactureraccessdata.fda.gov
WrenchHXC1Contract 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
August 4, 2017K170861PremierNKBSubstantially EquivalentShandong Weigao Orthopaedic Device Co., Ltd.accessdata.fda.gov
April 1, 2016K160320PremierMNISubstantially EquivalentShandong Weigao Orthopaedic Device Co., Ltd.accessdata.fda.gov
July 15, 2014K133053MILESTONE SPINAL SYSTEMMAXSubstantially EquivalentWeigao Orthopaedic Device Co., Ltd.accessdata.fda.gov
April 12, 2013K122994INTRAMEDULLARY NAIL SYSTEMMNHSubstantially EquivalentWeigao Orthopaedic Device Co., Ltd.accessdata.fda.gov
April 5, 2013K130340LOCKING BONE PLATES AND SCREWSHRSSubstantially EquivalentWeigao Orthopaedic Device Co., Ltd.accessdata.fda.gov
February 1, 2013K123578ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentWeigao Orthopaedic Device Co., Ltd.accessdata.fda.gov
October 24, 2012K121312INTRAMEDULLARY NAIL SYSTEMHSBSubstantially EquivalentWeigao Orthopaedic Device Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 4, 2017. 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.