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Data / Medical devices / United States / Nexxt Spine LLC

Nexxt Spine LLC: FDA-registered device maker in Noblesville, IN, United States, 25 510(k) clearances

Nexxt Spine LLC is registered with the FDA (registration 3007922509) in Noblesville, IN, United States. It lists 20 device types. The FDA files 25 510(k) clearances under its listings, the newest dated March 14, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Nexxt Spine LLC
FDA registration number
3007922509
Address
14425 Bergen Blvd Suite B, Noblesville, IN, United States, 46060
Owner or operator
Nexxt Spine LLC (10030542)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer
First device listed
October 15, 2009
Registered through
2027
Brand names listed
Awl, Blade, Deformity Correxxion, Facet Fixx, Honour Spacer System, Inertia, Inertia Connexx, Inertia Connexx Deformity and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Manufactureraccessdata.fda.gov
AwlHWJ1Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Complaint file establishment, Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerHSN2Contract manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Complaint file establishment, Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Complaint file establishment, Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Complaint file establishment, Manufactureraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWUComplaint file establishment, Manufactureraccessdata.fda.gov
TampHXG1Complaint file establishment, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, 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 14, 2025K243838NEXXT MATRIXX® SI SystemOURSubstantially EquivalentNexxt Spineaccessdata.fda.gov
March 22, 2024K240690STRUXXURE® MCS Anterior Cervical Plate SystemKWQSubstantially EquivalentNexxt Spineaccessdata.fda.gov
July 20, 2023K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNKBSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
July 28, 2022K221905INERTIA CONNEXX Modular Pedicle Screw SystemNKBSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
March 31, 2022K220291NEXXT SPINE NAVIGATION SystemOLOSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
December 15, 2020K202230NEXXT MATRIXX Stand Alone ALIF SystemOVDSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
September 17, 2020K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemKWQSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
May 21, 2020K200969NEXXT MATRIXX SystemMAXSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
March 23, 2020K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemOVESubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
February 24, 2020K193412NEXXT MATRIXX SystemPLRSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
January 21, 2020K193370Nexxt Matrixx SystemMAXSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
January 9, 2020K192687TrellOss™-L MPFMAXSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
July 10, 2019K191408Nexxt Matrixx SystemMAXSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
May 31, 2019K190546NEXXT MATRIXX Stand Alone Cervical SystemOVESubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
November 13, 2018K182508Saxxony™ Posterior Cervical Thoracic SystemNKGSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
August 22, 2017K171140Matrixx SystemODPSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
April 26, 2016K153453Inertia Pedicle Screw and Deformity Correxxion SystemNKBSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
June 26, 2014K141376INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSMNHSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
December 19, 2013K133475STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSKWQSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
October 10, 2013K132412INERTIA MIS PEDICLE SCREW SYSTEMMNISubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
July 12, 2013K131417FACET FIXXMRWSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
June 13, 2012K120345HONOUR SPACER SYSTEMODPSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
December 20, 2010K101278INERTIA PEDICLE SCREW SYSTEMMNHSubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov
January 19, 2010K091936BLADE ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentNexxt Medical, Inc.accessdata.fda.gov
June 30, 2009K090984INERTIA PEDICLE SCREW SYSTEMMNISubstantially EquivalentNexxt Spine, LLCaccessdata.fda.gov

Compare with other makers

Updated March 14, 2025. 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.