VY SPINE, LLC

FDA Device Registration & Listing · Bountiful, UT, US · Registration 3019837678

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
3019837678
FEI Number
3019837678
Entity Name
VY SPINE, LLC
City/State/Country
Bountiful, UT, US
Establishment Address
545 West 500 South, Suite 100 & 110, Bountiful, UT 84010, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Vy Spine, LLC (Owner Number: 10082347)
Owner / Operator Contact Address
545 West 500 South #110, Bountiful, UT 84010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213219
PMA Number
N/A

All Registered Proprietary Names

ClariVy™ NanoVy™ Ti Cervical IBF System VyLinkTM Spinal Screw System VyPlate™ Anterior Cervical Plate System VySpan™ PCT System LumiVy™ Lumbar IBF System VyLam™ Laminoplasty System Reliance Cervical IBF System - PEEK HA Enhanced DiversiVy™ Facet Screw System ClariVy™ FortiVy™ OsteoVy™ Ti Lumbar IBF System FortiVy™ OsteoVy™ Ti NanoVy™ HA Lumbar IBF System ClariVy™ Cervical IBF System VyLink™ Spinal Screw System Reliance Spinal Screw System VyLam™ Laminoplasty System Reliance Posterior Cervical Thoracic System VySpan™ PCT System Reliance Cervical IBF System - Sterile, PEEK HA Enhanced VySpan™ PCT System LumiVy™ NanoVy™ Ti Lumbar IBF System UniVy™ OsteoVy™ Ti NanoVy™ HA Cervical IBF System VyWasher™ Buttress System

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 2026-01-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-01-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-11-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-11-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-11-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-08
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-01-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-11-16
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2026-01-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-03-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-03-02
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2026-04-08
LYQ Accessories, Fixation, Spinal Intervertebral Body Orthopedic Class 1 888.4540 2021-07-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-11-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-11-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-02
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-01-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-02
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2026-01-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-11-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-11-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-03-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-03-02
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-01-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-01-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-01-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-11-16

Official Correspondent

Jordan Hendrickson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
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

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 3019837678. Last updated year: 2026. Please use registration number 3019837678 when referencing this establishment in official correspondence.
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