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Data / Medical devices / United States / Nexus Spine, LLC.

Nexus Spine, LLC.: FDA-registered device maker in Lehi, UT, United States, 21 510(k) clearances

Nexus Spine, LLC. is registered with the FDA (registration 3018210489) in Lehi, UT, United States. It lists 12 device types. The FDA files 21 510(k) clearances under its listings, the newest dated June 22, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3018210489
Address
4421 N Thanksgiving Way, Suite 101, Lehi, UT, United States, 84043
Owner or operator
Nexus Spine, LLC. (10048422)
Roles
Complaint file establishment, Specification developer
First device listed
January 12, 2015
Registered through
2026
Brand names listed
Nexus Spine

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Specification developeraccessdata.fda.gov
RaspHTR1Specification developeraccessdata.fda.gov
TemplateHWT1Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.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
June 22, 2026K261279DeltaNEC Interbody SystemOVESubstantially EquivalentNexus Spineaccessdata.fda.gov
October 14, 2025K253331PressON Spinal Fixation SystemNKBSubstantially EquivalentNexus Spineaccessdata.fda.gov
April 30, 2025K243934Stable-L Lumbar Interbody SystemOVDSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
July 17, 2024K241467Stable-C Interbody SystemOVESubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
March 20, 2024K233375Tranquil-L Interbody SystemMAXSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
March 12, 2024K240416Tranquil-C Interbody SystemODPSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
October 26, 2023K233234PressON Spinal Fixation SystemNKBSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
October 12, 2023K231486Stable-L Standalone Lumbar Interbody SystemOVDSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
September 18, 2023K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVDSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
August 21, 2023K231763Stable-C Interbody SystemOVESubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
May 2, 2023K223529PressON Spinal Fixation SystemNKBSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
February 2, 2023K223627PreView-III™ Anterior Cervical Plate SystemKWQSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
March 18, 2022K212498Stable-L Standalone Lumbar Interbody SystemOVDSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
October 19, 2018K181621Stable-C Interbody SystemOVESubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
September 21, 2018K181702Tranquil-L Interbody SystemMAXSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
August 27, 2018K181483Tranquil Interbody SystemMAXSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
June 27, 2017K170297Tranquil Interbody SystemMAXSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
June 28, 2016K160820PressON Pro Spinal Fixation SystemNKBSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
February 25, 2014K133287PRESSON SPINAL FIXATION SYSTEMMNHSubstantially EquivalentNexus Spine, LLCaccessdata.fda.gov
July 3, 2008K073500ACTIVE ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentSanacoraccessdata.fda.gov
December 4, 2006K062371PREVIEW ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentAlphaspine, Inc.accessdata.fda.gov

Compare with other makers

Updated June 22, 2026. 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.