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Data / Medical devices / United States / Solco Biomedical Corp.

Solco Biomedical Corp.: FDA-registered device maker in Carrollton, TX, United States, 29 510(k) clearances

Solco Biomedical Corp. is registered with the FDA (registration 3010509633) in Carrollton, TX, United States. It lists 28 device types. The FDA files 29 510(k) clearances under its listings, the newest dated January 18, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Solco Biomedical Corp.
FDA registration number
3010509633
Address
4100 Midway Rd Ste 1130, Carrollton, TX, United States, 75007
Owner or operator
SOLCO BIOMEDICAL CORPORATION (10045137)
Roles
Repackager or relabeler
First device listed
October 23, 2013
Registered through
2026
Brand names listed
4 Hex Driver, Cannulated, 4CIS Chiron Hex Rod Driver, 4CIS Chiron Reduction Screw Driver Navigation Type, 4CIS Chiron Screw Driver Navigation Type, 4CIS Chiron Tap Cannul 5.5 Navigation Type, 4CIS Chiron Tap Cannul 6.5 Navigation Type, 4CIS Chiron Tap Cannul 7.5 Navigation Type, 4CIS Chiron-XT Screw Driver Navigation Type and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
BenderHXW1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Burr, OrthopedicHTT1Repackager or relabeleraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Hook, BoneKIK1Repackager or relabeleraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Repackager or relabeleraccessdata.fda.gov
Instrument, CompressionHWN1Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Repackager or relabeleraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Repackager or relabeleraccessdata.fda.gov
Plate, Fixation, BoneHRS2Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, BoneHWC2Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Screwdriver, SurgicalLRZ1Repackager or relabeleraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Repackager or relabeleraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Repackager or relabeleraccessdata.fda.gov
Twister, WireHXS1Repackager or relabeleraccessdata.fda.gov
Washer, Bolt NutHTN2Repackager or relabeleraccessdata.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
January 18, 2024K231860TDM Screw SystemHWCSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
August 17, 2022K221844TDM Lumbar Interbody Fusion Cage SystemMAXSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
June 1, 2022K2032334CIS Chiron Spinal Fixation SystemNKBSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
May 19, 2022K220285PINE Pedicle Screw SystemNKBSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
March 19, 2020K191057Park's Pectus SystemHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
December 19, 2019K1920444CIS Marlin PEEK ACIF CageODPSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
November 15, 2019K190391TDM Plate and Screw SystemsHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
September 18, 2019K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF CageMAXSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
September 13, 2019K190830TDM Screw SystemsHWCSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
July 24, 2019K1904714CIS® Chiron Spinal Fixation SystemNKBSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
January 16, 2019K1824894CIS® Pinehurst Anterior Cervical Plate systemKWQSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
March 15, 2018K171808TDM Plate and Screw SystemHRSSubstantially EquivalentTdm Co., Ltd.accessdata.fda.gov
February 16, 2017K1624024CIS® Marlin ACIF Cage SystemODPSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
February 6, 2017K162283DCM Kyphoplasty SystemNDNSubstantially EquivalentDragon Crown Medical Co., Ltd.accessdata.fda.gov
July 29, 2016K153296MEDINAUT Kyphoplasty SystemNDNSubstantially EquivalentImedicom Co., Ltd.accessdata.fda.gov
January 14, 2016K151468ARIX Wrist SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
April 4, 2014K133669MEDINAUT KYPHOPLASTY SYSTEMNDNSubstantially EquivalentImedicomaccessdata.fda.gov
December 18, 2013K132876ARIX HAND LOCKING SYSTEMHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
November 4, 2013K131566ARIX HAND SYSTEMHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
August 15, 2012K1216154CIS VANE SPINE SYSTEMMNISubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
June 13, 2011K1024584CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEMMNHSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
February 11, 2011K1018184CIS VANE SPINE SYSTEMMNHSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
January 6, 2010K0921624CIS PEEK, PLIF AND TLIF CAGE SYSTEMMAXSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
November 5, 2008K081145MODIFICATION TO 4CIS VANE SPINE SYSTEMMNISubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
September 23, 2008K0824534CIS SOLAR AND APOLLON SPINE SYSTEMSMNHSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
June 22, 2006K0607024CIS VANE SPINE SYSTEMMNHSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
July 11, 2005K051155SOLCO 4CIS GENERAL PLATE SYSTEMHRSSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
May 12, 2005K0504714CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEMMNHSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov
March 7, 2005K043578THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEMMNHSubstantially EquivalentSolco Biomedical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 18, 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.