NEXUS SPINE, LLC.

FDA Device Registration & Listing · Draper, UT, US · Registration 3018210489

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018210489
FEI Number
3018210489
Entity Name
NEXUS SPINE, LLC.
City/State/Country
Draper, UT, US
Establishment Address
13867 South Bangerter Parkway, Suite 150, Draper, UT 84020, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Nexus Spine, LLC. (Owner Number: 10048422)
Owner / Operator Contact Address
2825 E Cottonwood Parkway Suite 330, Salt Lake City, UT 84121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170297
PMA Number
N/A

All Registered Proprietary Names

Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine Nexus Spine

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-08-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-12-04
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-12-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-01-12
HWT Template Orthopedic Class 1 888.4800 2017-05-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-15
HTR Rasp General, Plastic Surgery Class 1 878.4800 2017-05-09
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-05-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-04-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-04-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-02-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-04-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-04-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-04-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-04-11
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-04-11
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-05-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-12-04
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-12-04
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-08-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-05-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-04-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-04-13

Official Correspondent

Jared Crocker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nexus Spine, LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011390763 NEXUS SPINE, L.L.C. Salt Lake City, UT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018210489. Last updated year: 2026. Please use registration number 3018210489 when referencing this establishment in official correspondence.
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