Choice Spine LLC

FDA Device Registration & Listing · Knoxville, TN, US · Registration 3005819474

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
3005819474
FEI Number
3005819474
Entity Name
Choice Spine LLC
City/State/Country
Knoxville, TN, US
Establishment Address
400 Erin Dr, Knoxville, TN 37919, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
CHOICE SPINE, LLC (Owner Number: 9090881)
Owner / Operator Contact Address
400 ERIN DRIVE, Knoxville, TN 37919, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170821
PMA Number
N/A

All Registered Proprietary Names

ORIA SCS Extended Omniaxial Conn. Thunderbolt & Lancer Open Pedicle Screw System Ascendant PC Octance Straight PC Choice Spine TiGer Shark System Stratofuse BA Thunderbolt & Lancer Open Pedicle screw System Gilbralt Blackhawk Cervical Spacer System Tomcat Cervical Spinal System Blackhawk Ti SA Choice Spine Navigation System SIlverbolt/Mainframe ORIA Claris Connector Claris Lateral Connector, AL06 VEO Lateral Access & Interbody Fusion Sy stem Ascendant Cervical PEEK Spacer Choice Spine Cervical Spacer STEALTH Cervical Spacer STEALTH Cervical Fusion Device Choice Spine Navigation System Tomcat Cervical Spine System Gilbralt Cannulated Facet Screw Hawkeye Ti Blackhawk Cervical Spacer Gibralt Tiger Shark C ORIA SCS Lateral Intermediate Conn. Raven Lumbar Plate System Typhoon Choice Spine Vertebral Body Replacement (VBR) System Blackhawk Ti Thunderbolt and Lancer Pedicle Screw System Gibralt ORIA Spinal Clip System (SCS) Spinal Clip System (SCS) SCS SCS CLARIS ORIA CLARIS Harrier Octane Straight ORIA SCS Sacral Connectors ORIA SCS Lengthened Lateral Conn. Tiger Shark C Types BD & BJ Polyaxial Screws ORIA Spinal Clip System (SCS) ORIA SCS Polyaxial Screws ORIA SCS ORIA Spinal Clip System (SCS) Connector Transverse, Large Transverse Connector, Large DTO2 Transverse Connector ORIA Transverse Connector Blackbird HLS (Hinged Laminoplasty System) FALCON Anterior Cervical Plate FALCON ACP Choice Spine ACP System Anterior Cervical Plate (ACP) Gibralt OCP VEO Lateral Access & Interbody Fusion System ORIA System Domino/Tube Connectors Ambassador Harrier-SA Lumbar Interbody System ALTES Thunderbolt & Lancer Pedicle Screws With Hooks Claris Plate System Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusi SCS CLARIS ORIA CLARIS SCS ORIA Claris OmniAxial Connector Claris Connector Harrier-SA ORIA Xena Spinal Clip System Xena Top Loading Polyaxial Screw ORIA Xena Top Clip System Xena Polyaxial Screw Choice Spine Orthopedic Manual Surgical Instrument Various orthopedic screwdrivers ORIA NATURA Spacer NATURA ORIA NATURA NATURA VBR Boomerang Choice Spine STARFIRE Pedicle Screw System STARFIRE Screw STARFIRE Pedicle Screw System ORIA Spinal Clip System (SCS) Claris Vertebral Screws - V, G, E ORIA SCS Claris Vertebral Screws Proliant LE Pedicle Screw System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-02-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-02-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-03-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-03-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-01-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-14
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-03-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-03-03
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-03-03
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-12-28
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-12-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-10-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-03-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-03-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-03-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2007-12-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-12-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-04-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-03-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2009-12-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-03-20
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-04-21
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2017-03-03
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2019-03-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-03-20
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-12-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-03-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-02-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-03-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2014-07-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-07-09
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-07-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-12-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-12-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-12-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-03-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-03-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2006-12-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2006-12-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2006-12-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2006-12-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-02-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-02-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-03-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-02-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-02-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-03-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-12-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-12-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-12-05
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2018-01-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2010-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-03-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-02-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-02-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-03-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-05-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-03-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-06-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-06-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-06-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-06-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-02-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-06-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-06-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2006-12-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2006-12-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2006-12-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2006-12-20
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2018-07-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-07-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-05
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-12-10
HXX Screwdriver Orthopedic Class 1 888.4540 2007-12-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-08-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2008-08-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-05-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2010-11-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2010-11-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2010-11-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2007-12-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-12-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-14

Official Correspondent

Kim Finch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CHOICE 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
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005819474. Last updated year: 2026. Please use registration number 3005819474 when referencing this establishment in official correspondence.
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